BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ATT

    MDR report key: 3829987 · Received May 23, 2014

    Report

    Report Number
    3005075853-2014-03512
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    March 27, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE TISSUE PAD DAMAGED, MELTED, AND A SMALL PORTION WAS NOT RETURNED. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND NO ASSEMBLY ISSUES WERE NOTED. DURING FUNCTIONAL TESTING, NO ALERT SCREEN WERE DISPLAYED. PROBABLE CAUSES OF TISSUE PAD DAMAGE ARE APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. AVOID ACTIVATING THE BLADE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO PREVENT DAMAGE TO THE TISSUE PAD. IT IS POSSIBLE THAT THE REPORTING SMOKE WAS GENERATED BY THE TISSUE PAD BEING MELTED.

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TISSUE PAD FELL OFF AND THE DEVICE WOULD NOT ROTATE DURING A LAP LIVER RESECTION. THE TISSUE PAD DID NOT FALL INTO THE PATIENT. THE CASE WAS COMPLETED WITH A SECOND SAME DEVICE. NO PATIENT CONSEQUENCE. DEVICE WILL BE RETURNED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308181 HARMONIC ACE ATT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE