BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3142337 · Received June 3, 2013

    Report

    Report Number
    3005075853-2013-02729
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 15, 2013
    Report Date
    June 24, 2013
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE TISSUE PAD DAMAGED AND MELTED. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GEN11 AND IT DID ACTIVATE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 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 AN UNKNOWN PROCEDURE THE DEVICE LOST THE TISSUE PAD OUTSIDE THE PATIENT. ANOTHER DEVICE LIKE DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243463 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE