BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAMANTYS 6.0 BIPOLAR SEALER

    MDR report key: 3050319 · Received March 21, 2013

    Report

    Report Number
    MW5029689
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AQUAMANTYS HAND PIECE NOT WORKING. NO HEAT ACTIVATION. HAND PIECE REMOVED. REQUIRED NEW HAND PIECE TO COMPLETE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116858 AQUAMANTYS 6.0 BIPOLAR SEALER BIPOLAR SEALER GEI MEDTRONIC ADVANCED ENERGY LLC 21235202

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention