BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17046039 · Received June 2, 2023

    Report

    Report Number
    2955842-2023-15530
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    January 24, 2022
    Report Date
    January 28, 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
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOSCOPE ASSOCIATED WITH THE REPORTED EVENT AND COMPLETED A DEVICE EVALUATION. FAILURE ANALYSIS FOUND THE ENDOSCOPE TO HAVE CAMERA INSTRUMENT ADAPTER BINDING/FRICTION ISSUE. ADDITIONAL FINDING NOT REPORTED BY THE SITE: COSMETIC DAMAGE WAS FOUND TO THE LASER MARKINGS ON THE ENDOSCOPE'S HOUSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE PLUS WAS OBSERVED TO HAVE LOST ORIENTATION AUTOMATICALLY. THERE WAS A SOUND COMING FROM THE BASE/HOUSING WHEN MOVING THE DEGREE OF THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322893 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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