BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3760766 · Received April 21, 2014

    Report

    Report Number
    3005075853-2014-02599
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 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
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. 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. 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 HAND ACTIVATION BUTTONS TO BE NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE DAMAGE TO THE HAND ACTIVATION BUTTONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FIRST AND SECOND ACE36E DEVICES DID NOT WORK. THE THIRD ACE36E DEVICE FAILED TO WORK NEAR THE END OF THE PROCEDURE. THE FOURTH ACE36E DEVICE FROM DIFFERENT LOT NUMBER WORKED WELL. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239993 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE