BEUDAMED
    FDA Adverse Event Summary report: N

    INTUITIVE SURGICAL INC, MEGA NEEDLE DRIVER

    MDR report key: 3690847 · Received March 13, 2014

    Report

    Report Number
    MW5035029
    Date Received
    March 13, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 13, 2014
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT AND ELECTIVE ROBOTIC HYSTERECTOMY WITH THE DA VINCI ROBOT. DURING THE GRASP AND CAUTERY THE LEFT UTERO-OVARIAN LIGAMENT AND PEDICLES, THE VESSEL SEALER INSTRUMENT FAILED. THERE WAS INSUFFICIENT CAUTERY ON THE LEFT TO CONTROL BLEEDING OF THE IT. PEDICLE. PRODUCT REP IN OPERATING ROOM WAS CONSULTED. THE TROCAR WITH THE FAILED VESSEL SEALER WERE REMOVED TOGETHER. THE TROCAR WAS REPLACED AND LIGATURE FOR RIGHT WAS THEN MOVED TO LEFT. ONCE THIS PROCESS WAS SAFELY RESOLVED, THE HYSTERECTOMY WAS COMPLETED. SURGEONS VISUAL INSPECTION; IT APPEARED THE BLADE MALFUNCTIONED AND DID NOT ALLOW THE VESSEL SEALER TO CLOSE COMPLETELY. VESSEL SEALER BROUGHT THRU PORT, HUT UNABLE TO COME THROUGH THE TROCAR. OTHER DA VINCI ROBOTIC SUPPLIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150535 INTUITIVE SURGICAL INC, MEGA NEEDLE DRIVER 8 MM VESSEL SEALER NAY INTUITIVE SURGICAL M1013104

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention