BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3831939 · Received May 27, 2014

    Report

    Report Number
    3005075853-2014-03541
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    March 31, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS FUNCTIONALLY TESTED ON THE GENERATOR AND THE MIN HAND ACTIVATION BUTTON WAS NOT FUNCTIONAL. HOWEVER, THE DEVICE DID ACTIVATE WHEN TESTED WITH THE FOOT SWITCH AND NO ALERT SCREENS WERE DISPLAYED. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS. THE ELECTRICAL TRACES OF THE HAND ACTIVATION BUTTONS WERE FOUND TO BE DAMAGED. THIS RESULTED IN THE MIN HAND ACTIVATION BUTTON TO BE NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE DAMAGED TO THE ELECTRICAL TRACES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ¿LEBERZYSTE¿ PROCEDURE, THE GENERATOR SHOWED ERROR CODE: REDUCE PRESSURE ON BLADE; WITH GEN11. NO FURTHER INFORMATION IS AVAILABLE. NO PATIENT CONSEQUENCES REPORTED. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311701 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE