BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACE

    MDR report key: 1075498 · Received July 9, 2008

    Report

    Report Number
    1075498
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 9, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    THE 36CM LONG ASCENT HARMONIC ACE SCALPEL WAS USED ONE TIME AND THEN IT WOULD NOT WORK AGAIN. THIS DEVICE PASSED THE SELF TEST PRIOR TO USE. THE CATALOG AND LOT NUMBERS FOR THIS DEVICE WERE ACE36P AND 161406 RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE SCALPEL, HARMONIC LFL ASCENT HEALTHCARE SOLUTIONS * 161406

    Patients

    Seq Age Sex Outcome Treatment
    1 *