BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18044915 · Received November 1, 2023

    Report

    Report Number
    2955842-2023-19833
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    July 18, 2023
    Report Date
    October 11, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112366
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD A WIRE STICKING OUT WHILE ADVANCING OUT OF TROCAR INTO PATIENT ABDOMEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200361 ENDOWRIST TENACULUM FORCEPS NAY INTUITIVE SURGICAL, INC 470207-10 K10220718 0050 00886874112366

    Patients

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