BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAMANTYS MINI EVS

    MDR report key: 2870317 · Received December 12, 2012

    Report

    Report Number
    1226420-2012-00100
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 6, 2012
    Report Date
    December 12, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K063639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD AND RESULTS: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. PRODUCT EVENT: (B)(6).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    RANDOM ACTIVATION WITHOUT THE SURGEON DEPRESSING THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAMANTYS MINI EVS ELECTROSURGICAL DEVICE GEI MEDTRONIC ADVANCED ENERGY, LLC 23-314-1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1