BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA SYSTEM, NIR FI LIGHT SOURCE

    MDR report key: 25185844 · Received May 15, 2026

    Report

    Report Number
    2955842-2026-25201
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 15, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. BLANK MDR FIELDS:

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HANDHELD CAMERA BURNED A HOLE IN A DRAPE BECAUSE THE HANDHELD WAS NOT SCREWED ON CORRECTLY. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IT WAS CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT AND SURGICAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334197 CAMERA SYSTEM, NIR FI LIGHT SOURCE NIR HANDHELD CAMERA (SCHOELLY OEM 95-390) GCJ SCHOELLY FIBEROPTIC GMBH 470655 N/A

    Patients

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