BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIR HANDHELD CAMERA

    MDR report key: 24631003 · Received March 18, 2026

    Report

    Report Number
    2955842-2026-16569
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    July 9, 2024
    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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA WAS NOT ISSUED FOR RETURN AND THE CUSTOMER DID NOT RETURN THE PRODUCT FOR ANALYSIS. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. SINCE THE PRODUCT WAS NOT RETURNED AND THE EVENT LOGS VERIFICATION WAS NOT PERFORMED, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED OR REPLICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER DID NOT DISCONNECT THE LIGHT SOURCE GUIDE AND IT BURNED A HOLE THROUGH THE DRAPE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685701 NIR HANDHELD CAMERA CAMERA SYSTEM, NIR FI LIGHT SOURCE GCJ SCHOELLY FIBEROPTIC GMBH 470655-01 470655

    Patients

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