BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAMANTYS 6.0 BIPOLAR SEALER

    MDR report key: 6925813 · Received October 6, 2017

    Report

    Report Number
    1226420-2017-00248
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    September 7, 2017
    Report Date
    September 7, 2017
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4).

    Description of Event or Problem · 1

    DURING AN ORTHO CASE, WHILE USING SUCTION, HEATED SALINE FROM THE AQUAMANTYS DEVICE RAN OFF ONTO THE PATIENT¿S LEG RESULTING IN A BURN. THE BURN WAS APPROXIMATELY 4 INCHES LONG, THE DEGREE IS UNKNOWN. THE BURN WAS TREATED WITH AN ANTIMICROBIAL DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700496 AQUAMANTYS 6.0 BIPOLAR SEALER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 23-112-1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention