BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19378976 · Received May 23, 2024

    Report

    Report Number
    2955842-2024-14976
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    May 10, 2024
    Report Date
    May 10, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) HAS REQUESTED THAT THE 8MM MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS TESTING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE 8MM MEGA SUTURECUT NEEDLE DRIVER (ND) INSTRUMENT HAD A BROKEN/FRAYED WIRE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI OBTAINED THE FOLLOWING INFORMATION BASED ON A FOLLOW-UP: HI, WE WERE PERFORMING AN INGUINAL HERNIA REPAIR ON THE PATIENT VIA THE XI. AS WE WERE SUTURING, WE NOTICED THE MEGA SUTURE CUT TIP DISPLAYING WIRES THAT WERE LOOSE AND DISCONNECTED. THE SURGEON DECIDED THAT IT WAS NOT A GOOD IDEA TO HAVE IT IN THE PATIENT AND WE TOOK IT OUT AND REPLACED IT WITH A NEW ONE. NO FURTHER COMPLICATIONS OCCURRED AFTERWARDS. HOW THAT HAPPENED, WE ARE NOT SURE. POSSIBLY THE CONSTANT USE OF THE INSTRUMENT OVER A PROLONGED PERIOD OF TIME CAUSED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608188 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K14240111 0201 00886874119815

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES