BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIR HANDHELD CAMERA

    MDR report key: 24631889 · Received March 18, 2026

    Report

    Report Number
    2955842-2026-16581
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    December 5, 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
    MT, 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. WHILE THE DEFINITIVE ROOT CAUSE IS NOT ESTABLISHED, POSSIBLE CAUSE IS ATTRIBUTED TO USAGE-RELATED CONDITIONS, KEEPING THE LIGHT CORD AND LAPAROSCOPE IN CLOSE PROXIMITY TO DRAPES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON INDICATED THAT THEY HAD THE LIGHT CORD DISCONNECTED AND HAD BURNED THROUGH THE STERILE DRAPE. THE PATIENT DID NOT SUSTAIN AN INJURY DUE TO THE EVENT. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE EVENT WAS CONFIRMED. DURING THE PROCEDURE, THE SCHOELLY LIGHT CORD WAS HOT, CAUSING A BURN TO THE STERILE DRAPES. THE PATIENT DID NOT SUSTAIN AN INJURY DUE TO THE EVENT, NO INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164706 NIR HANDHELD CAMERA CAMERA SYSTEM, NIR FI LIGHT SOURCE GCJ SCHOELLY FIBEROPTIC GMBH 470655-01 470655

    Patients

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