BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3961835 · Received July 28, 2014

    Report

    Report Number
    3005075853-2014-05269
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED WITH THE TISSUE PAD DAMAGED, MELTED, AND THE HALF PORTION WAS NOT RETURNED. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GENERATOR AND IT ACTIVATED DURING FUNCTIONAL TESTING. 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. DUE TO THE CONDITION OF THE DEVICE, IT WAS UNABLE TO INVESTIGATE FURTHER THE HEMOSTASIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 SLEEVE PROCEDURE, THE TISSUE PAD FELL OFF OF THE HARMONIC WHEN THE SURGEON USED THE HARMONIC TO CONTROL BLEEDING ON THE LIVER BED WITH THE JAWS CLOSED. THERE WERE NO PATIENT CONSEQUENCES. 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
    439708 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA L4EA9C

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE