BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3791866 · Received May 6, 2014

    Report

    Report Number
    3005075853-2014-02990
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 5, 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
    JA
    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 A GEN04 AND THE MIN HAND ACTIVATION BUTTON WAS NOT FUNCTIONAL. HOWEVER, THE DEVICE DID ACTIVATE WHEN TESTED WITH THE FOOTSWITCH. 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 SIGMOIDECTOMY, THE DEVICE BECAME NOT TO BE ACTIVATED WITH THE MIN BUTTON DURING USE. THE BLADE TIP WAS NOT BROKEN OFF AND NO PIECES FELL INTO THE PATIENT. GEN04 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272199 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK K92V35

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE