BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2211784 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03302
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    August 8, 2011
    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
    AS
    Reporter Occupation
    OTHER

    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 Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE HARMONIC CURVED SHEARS BROKE, WHERE ONE SIDE OF THE SHEARS CAME AWAY FROM THE INSTRUMENT WHILE REMOVING/WIPING AWAY CAUTERIZED DEBRIS. THE BROKEN PIECE WILL BE RETURNED WITH THE INSTRUMENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION REQUESTED AS TO WHAT BROKE (EVENT STATES "ONE SIDE").

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK HG0G89

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE