BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17067259 · Received June 5, 2023

    Report

    Report Number
    2955842-2023-15677
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    April 30, 2022
    Report Date
    May 3, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOSCOPE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED/REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE ENDOSCOPE WAS EVALUATED AND FOUND THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY DUE TO INCREASED FRICTION AT THE BEARING. ALSO, THE LASER MARKINGS ON THE HOUSING WERE FOUND TO BE DAMAGED. ADDITIONALLY, THE ENDOSCOPE WAS FOUND WITH DISCOLORATION OF THE INTEGRATED CONNECTOR (IC) HOUSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE PLUS CAMERA WAS SHOWING THE IMAGE ROTATED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021278 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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