BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2963911 · Received February 15, 2013

    Report

    Report Number
    3005075853-2013-00663
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 14, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE THE DEVICE WAS BEING ACTIVATED ON TISSUE AND THE RECEIVED A "RELAX PRESSURE ON THE BLADE" ERROR. THEY KEPT ACTIVATING AND THE ACTIVE BLADE BROKE AND FELL INTO THE PATIENT. ALL PIECES WERE REMOVED, NO X-RAY WAS TAKEN. THEY USED A SECOND DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69352 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE