BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3102915 · Received May 9, 2013

    Report

    Report Number
    3005075853-2013-02200
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    May 1, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    RECEIVED A USER FACILITY MEDWATCH# (B)(4) ADVISING THAT DURING AN UNKNOWN PROCEDURE, THE HARMONIC SCALPEL STOPPED WORKING. THE INSTRUMENT WAS GIVEN TO THE SCRUB STAFF TO CLEAN AND THE BLADE OF THE HARMONIC SCALPEL BROKE OFF AS THE TIP WAS GENTLY CLEANED. ALL OF THE PIECES WERE RECOVERED. NO HARM TO THE PATIENT. DEVICE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202848 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J4C668

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR GENERATOR AND HANDPIECE