BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIR HANDHELD CAMERA

    MDR report key: 24630505 · Received March 18, 2026

    Report

    Report Number
    2955842-2026-16586
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    May 9, 2024
    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
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS REPRODUCIBLE. THE FSE CONTACTED THE SITE'S ROBOTIC COORDINATOR (ROCO) AND IDENTIFIED THE ISSUE TO BE ASSOCIATED WITH FAILING CAMERA LIGHT CORD. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. ISI HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, THE USER HAD NOTICED THE NEAR INFRARED (NIR) HANDHELD CAMERA LIGHT GUIDE ADAPTER TO THE LIGHT SOURCE WAS GETTING TOO HOT FOR THEM TO HANDLE. THE CUSTOMER INFORMED THEY HAD TRIED A SECOND LIGHT GUIDE AND HAD THE SAME ISSUE. THE LIGHT GUIDE WAS FINE, BUT IT WAS THE ADAPTER GOING INTO THE LIGHT SOURCE THAT GOT VERY HOT. THERE WAS NO REPORTED PATIENT IMPACT OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686409 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