BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3980461 · Received August 5, 2014

    Report

    Report Number
    3005075853-2014-05469
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 29, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH TISSUE PAD DETACHED BUT WITH EVIDENCE OF THE TISSUE PAD MATERIAL IN THE GROOVE SECTION OF THE CLAMP ARM. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GENERATOR AND THE DEVICE DID ACTIVATE DURING FUNCTIONAL TESTING. BASED ON THE CONDITION OF THE TISSUE PAD, A PROBABLE CAUSE FOR THIS DAMAGE IS THAT THE CLAMP OF THE DEVICE MAY HAVE BEEN CLOSED AND THE INSTRUMENT ACTIVATED WITHOUT TISSUE PRESENT. CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. KEEP THE CLAMP ARM OPEN WHEN BACK-CUTTING OR WHILE THE BLADE IS ACTIVE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. THE RESULTING DAMAGE CONTRIBUTES TO THE REMOVAL OF THE PAD FROM THE CLAMP ARM. CLEANING OF THE PAD, NOT IN ACCORDANCE WITH THE IFU CAN ALSO RESULT IN REMOVAL OF THE PAD DURING USE.

    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 LAPAROSCOPIC SLEEVE GASTRECTOMY THE TISSUE PAD FROM THE DEVICE DISLODGED INTO THE PATIENT. THE TISSUE PAD WAS RETRIEVED FROM THE PATIENT. IT WAS NOT REPORTED HOW THE CASE WAS COMPLETED BUT THERE WAS NO CONSEQUENCE TO THE PATIENT. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456684 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA K9193W

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE