BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1852230 · Received October 4, 2010

    Report

    Report Number
    3005075853-2010-05662
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 13, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS SHOWED THAT THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED. THE DEVICE WAS ACTIVATED WITH THE GENERATOR AND AN ERROR CODE 5 WAS DISPLAYED. PROBABLE CAUSES OF BLADE DAMAGE, INCLUDING BREAKAGE, ARE EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE, BLADE CONTACT WITH OTHER DEVICES, STAPLES OR CLIPS DURING THE PROCEDURE OR USING ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE BLADE. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN AN ERROR CODE 5 OR BLADE 'LOCKOUT' LATER IN THE PROCEDURE, AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE, A BEEP SOUND WAS HEARD AND THE DEVICE BECAME NOT TO BE ACTIVATED SUDDENLY. THE DEVICE WAS ACTIVATED A FEW TIMES, BUT THE MIST AND SMOKE REEKED UP A LOT. ALTHOUGH THE HANDPIECE WAS REPLACED, THE EVENT CONTINUED. ERROR 5 WAS ALSO DISPLAYED. THEY STOPPED USING THE DEVICE. SINCE THE DISSECTION HAD BEEN COMPLETED BEFORE THE EVENT, THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. WHEN THE DEVICE WAS CLEANED, THE BLADE BROKE OFF. NO PIECES WERE LEFT INSIDE THE PATIENT.

    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 G4TD5P

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE