BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17046586 · Received June 2, 2023

    Report

    Report Number
    2955842-2023-15480
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    February 27, 2023
    Report Date
    May 3, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112496
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TIP-UP FENESTRATED GRASPER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THE MAIN TUBE BROKEN. A PIECE MEASURING APPROXIMATELY 0.218¿ X 0.146¿ WAS NOT RETURNED WITH THE INSTRUMENT. THE INSTRUMENT HOUSING WAS REMOVED, AND THE CLAMPING PULLEY SCREWS WERE LOOSENED TO SEPARATE THE MAIN TUBE FROM THE PROXIMAL CLEVIS. VISUAL INSPECTION FOUND ALL INTERN CABLES TO BE STILL INTACT. SMALL PIECES FROM THE BROKEN MAIN TUBE WERE FOUND, BUT MATERIAL WAS STILL FOUND MISSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA-VINCI ASSISTED SURGICAL PROCEDURE, THE TIP-UP FENESTRATED GRASPER INSTRUMENT ENDOWRIST JAW BROKE AND DETACHED FROM THE SHAFT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP DA VINCI INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293255 ENDOWRIST TIP-UP FENESTRATED GRASPER NAY INTUITIVE SURGICAL, INC 470347-12 K10221113 0147 00886874112496

    Patients

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