BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3802501 · Received May 9, 2014

    Report

    Report Number
    3005075853-2014-03149
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    March 13, 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 HAND CONTROL BUTTONS WERE NOT FUNCTIONAL. HOWEVER, THE DEVICE DID ACTIVATE WHEN TESTED WITH THE FOOT SWITCH. NO ALERT SCREENS WERE DISPLAYED ON GENERATOR. THE DEVICE WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS. CORROSION WAS FOUND AT THE HAND ACTIVATION DOMES. THE CORROSION IN THE DOMES IS POSSIBLY CAUSED WHEN THE DEVICE WAS SOAKED FOR RE-USE OR THE DEVICE BEING SOAKED FOR CLEANING BEFORE SHIPMENT FOR ANALYSIS. THE ROOT CAUSE CANNOT BE IDENTIFIED BECAUSE IT IS UNKNOWN WHEN THE CORROSION OCCURRED. THE CORROSION WOULD HAVE INHIBITED ELECTRICAL CONTACT BETWEEN THE DOME AND THE CIRCUIT. OUR MANUFACTURING, STERILIZATION, PACKAGING AND SHIPMENT PROCESSES DO NOT INTRODUCE CORROSION TO THE DEVICE. IT IS PROBABLE THAT THIS MAY HAVE AFFECTED THE FUNCTIONALITY OF THE HAND ACTIVATION BUTTONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMA PROCEDURE GENERATOR SHOWED ERROR CODE: ¿REDUCE PRESSURE ON BLADE¿; ¿REPLACE INSTRUMENT¿; 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
    281315 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE