BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1830148 · Received September 10, 2010

    Report

    Report Number
    3005075853-2010-05186
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 18, 2010
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL. NO THERMAL ISSUES WERE NOTED ON THE BLADE TIP WHILE THE INSTRUMENT WAS BEING INSPECTED. TO AVOID USER OR PATIENT INJURY IN THE EVENT THAT ACCIDENTAL ACTIVATION OCCURS, THE INSTRUMENT BLADE, CLAMP ARM, AND DISTAL END OF THE SHAFT SHOULD NOT BE IN CONTACT WITH THE PATIENT, DRAPES, OR FLAMMABLE MATERIALS WHILE NOT IN USE. DURING PROLONGED ACTIVATION IN TISSUE, THE INSTRUMENT BLADE, CLAMP ARM, AND DISTAL 7 CM OF THE SHAFT MAY BECOME HOT. AVOID UNINTENDED CONTACT WITH TISSUE, DRAPES, SURGICAL GOWNS, OR OTHER UNINTENDED SITES AT ALL TIMES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS TESTED WITH A TEST GENERATOR AND HANDPIECE AND THE DEVICE ACTIVATED; FUNCTIONED NORMALLY DURING FUNCTIONAL TESTING, NO THERMAL ISSUES WERE NOTED ON THE BLADE TIP WHILE THE INSTRUMENT WAS BEING INSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT NEPHRECTOMY PROCEDURE, THE DEVICE GOT HOT AND IT BURNT THROUGH THE GOWN OF THE SCRUB TECH, BUT DID NOT RECEIVE A BURN. THE CUSTOMER FELT THAT THE BLADE TIP WAS HOTTER THAN IT SHOULD BE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE