BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIR HANDHELD CAMERA

    MDR report key: 24644826 · Received March 19, 2026

    Report

    Report Number
    2955842-2026-16582
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    August 6, 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
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED NOT TO USE THAT NIR UNIT UNTIL THE FIELD SERVICE ENGINEER (FSE) COULD INSPECT THE UNIT. TSE ADVISED TO TAG THE LIGHTGUIDE CABLE AS WELL AND NOT TO USE IT UNTIL IT WAS INSPECTED. 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. THERE WAS ALSO NO FIELD SERVICE ACTIVITY INITIATED FOLLOWING THIS EVENT. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. SINCE THE PRODUCT WAS NOT RETURNED, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED OR REPLICATED. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA SURGICAL PROCEDURE, THE SCHOELLY LIGHT CAMERA CORD BURNED THROUGH THE STERILE DRAPES AND THE MATTRESS. THE STAFF REMOVED THE LIGHT GUIDE FROM THE HANDHELD HEAD WHILE THE LIGHT WAS STILL ON. THE HEAT FROM THE TIP OF THE LIGHT GUIDE MELTED THE DRAPE AND DAMAGED THE BED. THE PATIENT DID NOT SUSTAIN AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698726 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