BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAMANTYS 2.3

    MDR report key: 1883568 · Received September 17, 2010

    Report

    Report Number
    1883568
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 17, 2010
    Manufacturer
    SALIENT SURGICAL TECHNOLOGIES
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE AQUAMANTYS 2.3 BIPOLAR SEALER DID NOT WORK WHEN ACTIVATED. THE AQUAMANTYS GENERATOR WAS RESTARTED; THE HAND PIECE WAS REINSERTED TO VERIFY THE CONNECTION TO THE GENERATOR. THE BIPOLAR HAND PIECE AGAIN DID NOT WORK WHEN PRESSING THE ACTIVATION BUTTON, THEN IT SUDDENLY STARTED WORKING, BUT ONLY INTERMITTENTLY. A NEW HAND PIECE WAS OPENED AND IT FUNCTIONED PROPERLY WITH THE SAME GENERATOR. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAMANTYS 2.3 BIPOLAR SEALER GEI SALIENT SURGICAL TECHNOLOGIES * PHD060AO

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR