BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIR HANDHELD CAMERA

    MDR report key: 24633779 · Received March 18, 2026

    Report

    Report Number
    2955842-2026-16560
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    December 22, 2025
    Report Date
    March 18, 2026
    Manufacturer
    SCHOELLY FIBEROPTIC GMBH
    Product Code
    GCJ
    PMA / PMN Number
    K221591
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. SINCE THE PRODUCT WAS NOT RETURNED AND THE ACCESSORY USAGE IS NOT TRACKED IN THE SYSTEM LOGS, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED OR REPLICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEAR INFRARED (NIR) HANDHELD CAMERA LIGHT CORD BECAME UNUSUALLY HOT AND BURNED SOME MATERIAL AND EQUIPMENT IN THE PROCEDURAL AREA. THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE LIGHT GUIDE CABLE TEMPERATURE ISSUE DID NOT CAUSE PATIENT HARM OR A STAFF INJURY. THE ISSUE ONLY RESULTED IN A BURN MARK ON THE DRAPE BEFORE IT WAS NOTICED AND HANDLED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691593 NIR HANDHELD CAMERA CAMERA SYSTEM, NIR FI LIGHT SOURCE GCJ SCHOELLY FIBEROPTIC GMBH 470655-01 N/A

    Patients

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