BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIR HANDHELD CAMERA

    MDR report key: 24644282 · Received March 19, 2026

    Report

    Report Number
    2955842-2026-16576
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    April 2, 2024
    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
    CA, 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE NEAR INFRARED (NIR) CAMERA LIGHT CORD WAS UNPROTECTED AND BURNED A HOLE IN THE DRAPE. THE CUSTOMER REPORTED THAT THE STERILE FIELD WAS NOT CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697258 NIR HANDHELD CAMERA CAMERA SYSTEM, NIR FI LIGHT SOURCE GCJ SCHOELLY FIBEROPTIC GMBH 470655-01 N/A

    Patients

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