BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 1852389 · Received September 30, 2010

    Report

    Report Number
    1852389
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY / LEFT SALPINGO-OOPHORECTOMY PROCEDURE, THE ASCENT REPROCESSED HARMONIC ACE SHEARS QUIT COAGULATING. SURGERY COMPLETED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC, HARMONIC SHEARS LFL ASCENT HEALTHCARE SOLUTIONS ACE36E 1183376

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR