BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER

    MDR report key: 3952674 · Received July 17, 2014

    Report

    Report Number
    MW5037361
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    April 15, 2014
    Report Date
    July 14, 2014
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ROBOTIC INGUINAL/UMBILICAL HERNIA REPAIR USING THE MEGA SUTURECUT NEEDLE DRIVER, WITH APPROX 2 MINUTE'S USE, THE CABLE CAME LOOSE FROM THE JAW OF THE NEEDLE DRIVER. INSTRUMENT WAS REPLACED WITH A NOW ONE AND DEFECTIVE INSTRUMENT OVER TO BIOMED (CHAIN OF CUSTODY). DIAGNOSIS OR REASON FOR USE: RT INGUINAL AND UMBILICAL HERNIA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420267 MEGA SUTURECUT NEEDLE DRIVER MEGA SUTURECUT NEEDLE DRIVER NAY INTUITIVE SURGICAL M10130725

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention