BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2981112 · Received February 27, 2013

    Report

    Report Number
    3005075853-2013-00880
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED: HOW DID THE INSTRUMENT ERROR AND EVENTUAL BLADE BREAKAGE OCCUR, AS THIS OCCURRED "AFTER THE SURGERY DURING TESTING?" WHAT IS MEANT BY "AFTER THE SURGERY DURING TESTING?" WAS ANALYSIS BEING PERFORMED ON THE DEVICE OUTSIDE OF THE OPERATING ROOM? WAS THE DEVICE BEING TESTED BY A HOSPITAL BIOMED? WAS THE DEVICE BEING TESTED BY THE REP? WAS THERE ANY ALERT SCREENS FROM THE GENERATOR THAT CAUSED SOMEONE TO TEST THE DEVICE AFTER SURGERY? DID THE DEVICE PERFORM AS EXPECTED DURING THE SURGERY?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICES WAS TESTED, AFTER THE SURGERY, AN INSTRUMENT ERROR WAS DISPLAYED AND THEN THE BLADE BROKE. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83444 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female GENERATO AND HANDPIECE| GENERATO AND HANDPIECE