BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3850019 · Received June 4, 2014

    Report

    Report Number
    3005075853-2014-03792
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 14, 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 WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND IT WAS RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED, EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. UPON TESTING IT WAS NOTED THAT THE HAND ACTIVATION CONTACTS WERE DAMAGED CAUSING DIFFICULTIES TO ROTATE THE SHAFT WHEN THE DEVICE WAS ASSEMBLED TO THE HANDPIECE. DUE TO THE DAMAGE FOUND ON THE HAND ACTIVATION CONTACTS, THE INSTRUMENT HAD TO BE TESTED WITH THE FOOTSWITCH AND AN ERROR CODE 5 WAS DISPLAYED DURING THE ANALYSIS. A PROBABLE CAUSE OF THE DEVICE STOP ACTIVATING AND DISPLAY AN ERROR CODE 5 IS BLADE DAMAGE. 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. THE GENERATOR SYSTEM WILL REVERT TO STANDBY MODE, WHEN THE AUDIBLE ALARM (SOLID TONE) AND VISUAL ALARM INDICATOR APPEAR. IT IS POSSIBLE THAT THE DAMAGE TO THE HAND ACTIVATION CONTACTS DID NOT ALLOW THE DEVICE TO BE TORQUE PROPERLY. THIS COULD HAVE RESULTED IN AN ERROR CODE MESSAGE. IT IS POSSIBLE THAT THE UNEXPECTED NOISE HEARD COULD BE EITHER DUE TO THE BLADE NOT BEING PROPERLY ATTACHED TO THE HANDPIECE OR THE SOLID TONE EMITTED WHEN THE BLADE BECOMES DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY, AN UNEXPECTED NOISE WAS HEARD DURING USE. GEN04 WAS USED. A COMPETITIVE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE BLADE WAS BROKEN OFF WHEN IT WAS CLEANED AFTER THE OPERATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326664 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE