BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIR HANDHELD CAMERA

    MDR report key: 24632256 · Received March 18, 2026

    Report

    Report Number
    2955842-2026-16564
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    September 18, 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
    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 REPORTED ISSUE CANNOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STAFF ENCOUNTERED AN ISSUE WHERE THE NEAR INFRARED (NIR) HANDHELD CAMERA LIGHT CORD AND SCOPE WERE GETTING VERY HOT. THE STAFF HELD THE CAMERA UP TO A DRAPE, AND THE SCOPE BURNED THROUGH THE DRAPE. THE ISSUE WAS NOTED DURING A PROCEDURE. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690922 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.