None 400624

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • Ongoing Z-2310-2026 FDA Class II ·initiated 24 Apr 2026 ·on shared 510(k) K232610

  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.

• • Ongoing Z-1355-2026 FDA Class II ·initiated 30 Dec 2025 ·on shared 510(k) K232610

  Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization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.

• • Ongoing Z-1428-2026 FDA Class II ·initiated 17 Nov 2025 ·on shared 510(k) K232610

  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.

• • Ongoing Z-1232-2026 FDA Class II ·initiated 7 Nov 2025 ·on shared 510(k) K232610

  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

• • Ongoing Z-1325-2025 FDA Class II ·initiated 26 Feb 2025 ·on shared 510(k) K232610

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

• • Ongoing Z-0964-2026 FDA Class II ·initiated 21 Aug 2024 ·on shared 510(k) K232610

  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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade Name

Da Vinci 5 Endoscope Tray EUDAMED

None GUDID

Generic Name

Instrument tray, reusable

Device Name

Reprocessing Accessories

Model / Reference

400624

Primary DI / UDI-DI

00886874123829

Basic UDI-DI

08868741200026S

FDA Product Code

KCT

EMDN Code

S9080 Devices for sterilisation (excluding cat. d - z) - accessories

GMDN Term

Instrument tray, reusable

Device Class

Class I EUDAMED

Class II GUDID

Regulation Number

880.6850

EU market of registration

Netherlands

GUDID distribution status

In Commercial Distribution

Category: Instrument tray, reusable

• da Vinci 5 Handheld Camera Head (470080)

  Class II

  FDA 510(k) K262455 Active Cleared 14 Oct 2026

• EndoWrist Stapler Release Kit, Czech

  Class I

  CE/MDR

• EndoWrist Stapler Release Kit, Greek

  Class I

  CE/MDR

• SP Endoscope Reprocessing Tray

  Class I

  CE/MDR

• EndoWrist Stapler Release Kit, Swedish

  Class I

  CE/MDR

• EndoWrist Instrument Release Kit, Spanish

  Class I

  CE/MDR

See all devices from Intuitive Surgical, Inc. →