BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIR HANDHELD CAMERA

    MDR report key: 24640826 · Received March 19, 2026

    Report

    Report Number
    2955842-2026-16587
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    May 13, 2025
    Report Date
    March 19, 2026
    Manufacturer
    SCHOELLY FIBEROPTIC GMBH
    Product Code
    GCJ
    UDI-DI
    04250480109076
    PMA / PMN Number
    K221591
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE HANDHELD CAMERA FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. ISI RECEIVED THE HANDHELD CAMERA LIGHT GUIDE INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE HANDHELD CAMERA LIGHT GUIDE WAS ANALYZED AND VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE WIRE WAS NOT BROKEN, AND THE INSULATION WAS STILL INTACT. THE HANDHELD CAMERA LIGHT GUIDE COULD NOT BE TESTED DUE TO NO SYSTEM AVAILABILITY. NO PRODUCT ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE NIR HANDHELD CAMERA BURNED A HOLE IN THE DRAPE AND WAS SMOKING. THE CAMERA LIGHT GUIDE CABLE WAS BURNED. THERE WAS NO HARM TO THE PATIENT. THE SITE COMPLETED THE CASE AND STATED THEY WOULD NOT USE CAMERA AND SCOPE UNTIL ISSUE HAD BEEN IDENTIFIED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT USER'S GLOVE WAS NOT BURNED. THERE WAS NO HARM TO THE PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699486 NIR HANDHELD CAMERA CAMERA SYSTEM, NIR FI LIGHT SOURCE GCJ SCHOELLY FIBEROPTIC GMBH 470655-01 N/A 04250480109076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DA VINCI INSTRUMENTS AND ACCESSORIES