BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 8635938 · Received May 23, 2019

    Report

    Report Number
    8635938
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    May 7, 2019
    Report Date
    May 8, 2019
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING ROBOTIC PROSTATECTOMY UNDER ANESTHESIA, DRAPED WITH THE ROBOT DOCKED. THE ROBOTIC 4TH ARM ACTIVATED THE BOVIE IN THE SIDE POCKET OF THE DRAPE. THE PATIENT EXPERIENCED A BURN ON THE PATIENT'S LEFT LOWER FLANK. APPROXIMATELY HALF AN INCH IN SIZE WITH NOTICEABLE CHARRED TISSUE. SURROUNDING AREA WHITE IN COLOR AND FIRM TO THE TOUCH. SITE REQUIRED 2 STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430269 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN LP E2515H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other