BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2954074 · Received February 11, 2013

    Report

    Report Number
    3005075853-2013-00546
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 2013
    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). DEVICE A WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED - EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON THE GEN11 GENERATOR, THE 'INSTRUMENT ERROR' ALERT WAS DISPLAYED; AND WHEN TESTED ON THE GEN04 GENERATOR, AN ERROR CODE 5 (INSTRUMENT ERROR) WAS DISPLAYED. A PROBABLE CAUSE OF THE DEVICE TO STOP ACTIVATING AND DISPLAY AN ERROR CODE 5 OR INSTRUMENT ERROR SCREEN 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 YELLOW ALERT SCREENS, SUCH AS 'REPLACE INSTRUMENT' WITH THE GEN11 LATER IN THE PROCEDURE, AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE. DEVICE B WAS RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL. IN ADDITION, THE DEVICE ACTIVATED WITH BOTH MAX AND MIN BUTTONS. THE TISSUE PAD OF THE DEVICE WAS IN GOOD PHYSICAL CONDITION. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. IT COULD NOT BE DETERMINED WHY A NOISE REPORTEDLY OCCURRED FROM THE SHAFT AND AN ERROR WAS DISPLAYED. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY, A NOISE OCCURRED FROM THE SHAFT AND AN ERROR WAS DISPLAYED. AN ERROR CODE WAS UNKNOWN. THE BLADE WAS BROKEN OFF WHEN THE DEVICE WAS ACTIVATED AGAIN. THE BROKEN BLADE FELL OUTSIDE PATIENT'S BODY. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. TWO DEVICES WILL BE RETURNING. ONE OF THEM WAS .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58507 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J92UOH

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE