BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16883484 · Received May 6, 2023

    Report

    Report Number
    2955842-2023-12808
    Event Type
    Malfunction
    Date Received
    May 6, 2023
    Date of Event
    December 10, 2020
    Report Date
    January 19, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 8MM PERMANENT CAUTERY HOOK INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE REPORTED FAILURE. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED FLUSH TUBE DETACHED FROM THE INSTRUMENT. THE FLUSH TUBE WAS RETURNED. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PLASTIC PROXIMAL CLEVIS AT THE DISTAL END.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE ¿TUBE WHERE LIQUID IS SENT THROUGH TO CLEAN CAME OUT OF THE INSTRUMENT¿ ON THE PERMANENT CAUTERY HOOK INSTRUMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574867 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-14 N11200211 0050 00886874112311

    Patients

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