BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIR HANDHELD CAMERA

    MDR report key: 24635114 · Received March 18, 2026

    Report

    Report Number
    2955842-2026-16553
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    April 17, 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
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED. THE CALLER STATED IT WAS ONLY SURFACE LEVEL AND NOT INTERNAL, BUT THEY WERE ABLE TO USE IT DURING THE PROCEDURE. CALLER WOULD REPROCESS SCOPE AND PUT BACK INTO CIRCULATION. 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 SCHOELLY CAMERA HEAD WAS MELTED CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. SINCE THE PRODUCT WAS NOT RETURNED AND THE LOG REVIEW WAS INCONCLUSIVE, 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 REPORTED THE NEAR INFRARED (NIR) HANDHELD CAMERA HEAD HAD MELTED ON THE SURFACE LEVEL. CALLER STATED IT WAS ONLY SURFACE LEVEL DAMAGE AND NOT INTERNAL, BUT THEY WERE ABLE TO USE IT DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695620 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