BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20341397 · Received October 1, 2024

    Report

    Report Number
    2955842-2024-20125
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Report Date
    September 10, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: SURGEON USING MEGA SUTURE CUT NEEDLE DRIVER DURING ROBOTIC UMBILICAL HERNIA REPAIR. INSTRUMENT WAS IN THE BELLY AND SUDDENLY WIRE IN BETWEEN TEETH WAS EXPOSED WHILE INSTRUMENT BEING USED. INSTRUMENT REMOVED INTACT AND NEW INSTRUMENT OPENED AND UTILIZED. DEFECTIVE INSTRUMENT TAGGED AND TAKEN DOWN TO DECONTAMINATION AND GIVEN TO [NAME REDACTED]. ALL MANAGEMENT STAFF AND PERI-OP STAFF INFORMED AND AWARE VIA GROUP ME. IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ROBOTIC UMBILICAL HERNIA REPAIR SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS IN THE BELLY AND WHEN SUDDENLY THE WIRE IN BETWEEN THE TEETH WAS EXPOSED. INSTRUMENT REMOVED INTACT AND NEW INSTRUMENT OPENED AND UTILIZED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF THE REPORTED EVENT HAD ANY IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948089 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-17 K10231207 0345

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown DA VINCI INSTRUMENTS AND ACCESSORIES