Intuitive Surgical, Inc.

Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.

Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.

Access Port System tray may develop cracks potentially resulting in a sterility breach.

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Due to probe bags that may have a compromised or incomplete sterile pouch seal.

An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.

Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure

There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.

Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.

There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.

Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.

Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.

Potential staple deployment failure and device fragment generation

Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery

Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.

As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitives existing risk documentation.

Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.

Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.

Incorrect expiration date on its package labeling (shipper box and inner carton label).

Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.

The distal tip ring of the fully articulating catheter may become dislodged during the procedure.

One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.

One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.

Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.

Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.

Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.

The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.

The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.

The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.

The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.

The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.

One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.

Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.

Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.

Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.

During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility.

This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits the activation of monopolar energy from the surgeon console.

Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.

Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.

The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.

The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.

Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.

Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.

Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.

The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.

Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.