BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2932732 · Received January 29, 2013

    Report

    Report Number
    3005075853-2013-00350
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 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). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    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

    Additional Manufacturer Narrative · 1

    (B)(4): ADDED ADDITIONAL INFORMATION 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. PROBABLE CAUSES OF TISSUE PAD DAMAGE ARE APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THE BLADE AND TISSUE PAD; 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 AN UNKNOWN PROCEDURE THE GENERATOR DISPLAYED THE MESSAGE TIGHTEN THE ASSEMBLY, AFTER 5 MINS OF USE. THEY TIGHTENED THE DEVICE AND THE TISSUE PAD DETACHED AND FELL INTO THE PATIENT. THEY REMOVED FULLY THE TISSUE PAD. ANOTHER DEVICE LIKE DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES. 1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38994 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J92E3C

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE