BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3872617 · Received June 13, 2014

    Report

    Report Number
    3005075853-2014-03984
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 6, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED WITH THE TISSUE PAD DAMAGED, MELTED, AND A PORTION WAS NOT RETURNED. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GENERATOR AND IT ACTIVATED DURING FUNCTIONAL TESTING. HOWEVER, DUE TO THE RETURNED CONDITION OF THE DEVICE NOT ALL FUNCTIONAL TESTING COULD BE PERFORMED. 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.

    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 DURING A HEPATIC PROCEDURE, THERE WAS LOSS OF SILICONE JAW, WHICH CAUSED DIFFICULTY IN CLOTTING STRUCTURES. DUE TO THIS SITUATION, CHOSE CONVENTIONAL TECHNIQUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349372 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE