BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIR HANDHELD CAMERA

    MDR report key: 24645936 · Received March 19, 2026

    Report

    Report Number
    2955842-2026-16562
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    September 19, 2025
    Report Date
    March 19, 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
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER AND SENT A PICTURE OF THE CAUTIONS LISTED FOR THE SCOPE TO SEE IF IT WAS THE ONLY NEEDED INFO, OR IF THERE WAS MORE THAT COULD BE SENT TO THE CUSTOMER. BOTH AGREED THAT THE PROVIDED PICTURE DETAILED THE PROPER CAUTIONS THAT SHOULD BE TAKEN. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THE PROBABLE ROOT CAUSE OF THE CUSTOMER ISSUE COULD NOT BE DETERMINED, AS NO PRODUCT WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE NEAR INFRARED (NIR) HANDHELD CAMERA LIGHT CORD AND LAPAROSCOPE WERE GETTING VERY HOT. THE CALLER REPORTED THAT THE SCOPE BURNED THROUGH A DRAPE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707010 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