BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAMANTYS MALLEABLE LIGHT DISPOSABLE

    MDR report key: 9516675 · Received December 23, 2019

    Report

    Report Number
    MW5091873
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    December 18, 2019
    Report Date
    December 20, 2019
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AQUAMANTYS MALLEABLE LIGHT DISPOSABLE BY MEDTRONIC ADVANCED ENERGY LLC, WAS BEING USED IN THE OPERATING ROOM. ONLY ONE PROBE ON THE DEVICE WAS WORKING. DEVICE REMOVED FROM SURGICAL FIELD. NEW DEVICE OPENED AND WORKED WITHOUT INCIDENT. SURGERY CONTINUED. NO HARM TO THE PATIENT FDA MEDWATCH COMPLETED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308776 AQUAMANTYS MALLEABLE LIGHT DISPOSABLE ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PHF079N0

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR