BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACE

    MDR report key: 1811821 · Received August 19, 2010

    Report

    Report Number
    1811821
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ASCENT
    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

    A PATIENT PRESENTED FOR A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY FOR PELVIC PAIN AFTER ENDOMETRIAL ABLATION WITH THICKEND ENDOMETRIUM WAS PERFORMED A MONTH EARLIER. THE REPROCESSED ACE HARMONIC WOULD NOT TEST. THE DEVICE WAS REMOVED FROM THE FIELD AND SWAPPED OUT FOR ANOTHER ONE THAT TESTED FINE AND WAS USED ON THE PATIENT WITHOUT PROBLEMS.====================== HEALTH PROFESSIONAL'S IMPRESSION======================EQUIPMENT MALFUNCTION - FAILED ORIGINAL TEST. THE REPROCESSED ACE HARMONIC SCALPELS HAVE BEEN A PROBLEM. PRIOR MEDWATCH REPORTS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE HARMONIC SCALPEL LFL ASCENT * 1161208

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR NONE NOTED