Reprocessed Endoscopic Trocars and Cannulas

• 3 recalls, same reason

  • Terminated Z-1834-2015 FDA Class II ·initiated 1 Jun 2015
  • Terminated Z-1836-2015 FDA Class II ·initiated 1 Jun 2015
  • Terminated Z-1835-2015 FDA Class II ·initiated 1 Jun 2015

  Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

510(k) Number

K063788 ↗

FDA Product Code

NLM

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Reprocessed Cs Bi-Diectional Diagnostic Electrophysiology Catheter Open recall

  Class II

  FDA 510(k) K100254 Active Cleared 28 May 2010

• Reprocessed External Fixation Device

  Class II

  FDA 510(k) K061759 Active Cleared 5 Sep 2006

• Reprocessed Diagnostic Ultrasound Catheter

  Class II

  FDA 510(k) K063076 Active Cleared 29 Mar 2007

• Reprocessed Electrosurgical Instrument

  Class II

  FDA 510(k) K110189 Active Cleared 18 Jul 2011

• Reprocessed Trocars

  Class II

  FDA 510(k) K070059 Active Cleared 2 Oct 2007

• Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9, Twblue, Gablue

  Unclassified

  FDA 510(k) K100537 Active Cleared 12 May 2010

See all devices from Ascent Healthcare Solutions →

• What are reprocessed endoscopic trocars and cannulas used for?

  These devices create a controlled entry point for endoscopic instruments during minimally invasive surgeries. They are designed to temporarily dilate access to abdominal, thoracic cavities, and hollow organs, enabling procedures like laparoscopic surgeries in gastroenterology and urology. The trocars and cannulas maintain sterility and functionality for reuse, ensuring safe and efficient surgical access.

• How are these reprocessed endoscopic trocars and cannulas supplied?

  The devices are supplied sterile and intended for single-use after reprocessing. Each package contains trocars, cannulas, obturators, and seals in various configurations, ready for immediate use in sterile surgical environments. Proper handling and storage are required to maintain sterility and performance.

• Are these devices single-use or reusable after reprocessing?

  These reprocessed endoscopic trocars and cannulas are intended for single-use following the manufacturer’s reprocessing procedures. While they are designed for reuse, they must undergo strict sterilization and quality checks to ensure safety and functionality. Reuse is only permitted after proper reprocessing and adherence to regulatory standards.

• What sizes or models are available for these reprocessed trocars and cannulas?

  The reprocessed endoscopic trocars and cannulas come in multiple configurations, including various diameters and lengths, to accommodate different surgical needs. Specific models are categorized under FDA product codes such as NLM and are tailored for use in laparoscopic procedures. Exact sizes should be verified against the packaging or manufacturer’s specifications.

• How should reprocessed endoscopic trocars and cannulas be stored?

  To preserve sterility and functionality, these devices must be stored in a clean, dry environment protected from moisture, dust, and direct sunlight. The packaging should remain intact until use, and storage conditions should comply with regulatory guidelines for reprocessed surgical instruments. Proper labeling and inventory tracking are also recommended.