BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENEVAC SS

    MDR report key: 1830671 · Received September 7, 2010

    Report

    Report Number
    1830671
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 20, 2010
    Manufacturer
    IC MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    SURGEON COMPLETING A BILATERAL BREAST REDUCTION AND THE TIP OF THE SUCTION BOVIE BROKE INTO PIECES DURING THE PROCEDURE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNKNOWN, ENTIRE SURGICAL TEAM SAID THE SURGEON WAS APPROPRIATELY USING THE DEVICE WHEN IT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENEVAC SS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI IC MEDICAL * 3712

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR