BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ATT

    MDR report key: 3884556 · Received June 19, 2014

    Report

    Report Number
    3005075853-2014-04156
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED WITH THE TISSUE PAD MELTED AND A SMALL PORTION WAS NOT RETURNED. IN ADDITION, DUE TO THE TISSUE PAD DAMAGE THE DISTAL OF THE CLAMP ARM AND THE BLADE TIP WAS DAMAGED. THE DEVICE WAS TESTED WITH A TEST HANDPIECE AND GENERATOR AND WAS FUNCTIONAL THE BLADE WAS NOTED TO HAVE MINOR DAMAGE AT THE TIP. THIS DAMAGE OCCURRED AFTER THE TISSUE PAD MELTED, EXPOSING THE CLAMP ARM AND ALLOWING THE BLADE TO MAKE CONTACT. IT IS POSSIBLE THAT THIS RESULTED IN AN ALERT SCREEN TO BE DISPLAYED DURING USE. THE DAMAGE TO THE TISSUE PAD DAMAGE MAY OCCUR WHEN APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM AND ACTIVATING THE BLADE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. BOTH CONDITIONS CAN RESULT IN PROBABLE DAMAGE TO THE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 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 DURING A LAPAROSCOPIC VENTRAL HERNIA PROCEDURE, THE REP WAS CALLED TO CASE SAYING PART OF THE TEFLON PAD FELL OFF (A FEW MM FROM THE TIP) OF A HARMONIC DEVICE. IT WAS REPORTED THAT THEY WERE TAKING DOWN A LOT OF ADHESIONS. THE BROKEN PIECE WAS UNABLE TO BE LOCATED IN THE PATIENT. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360722 HARMONIC ACE ATT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE