BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2082229 · Received May 9, 2011

    Report

    Report Number
    3005075853-2011-01880
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE TISSUE PAD MELTED AND PARTIALLY DETACHED. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GENERATOR AND THE DEVICE DID ACTIVATE DURING FUNCTIONAL TESTING. NO ISSUES THAT COULD AFFECT THE SEALING PERFORMANCE OF THE DEVICE WERE FOUND. PROBABLE CAUSES OF TISSUE PAD DAMAGE ARE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE TISSUE PAD FELL OFF OF THE DEVICE AFTER ABOUT 15-20 MINUTES OF USE. THE CALLER STATED THAT THERE WAS SOME BLEEDING DUE TO THE FAILURE OF THE DEVICE. THE AMOUNT IS UNKNOWN BUT NO BLOOD PRODUCTS WERE NEEDED. THE BLEEDING WAS CONTROLLED WITH THE USE OF ANOTHER DEVICE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK G9LG83

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE