BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2982408 · Received February 28, 2013

    Report

    Report Number
    3005075853-2013-00903
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 11, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. 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 NOT 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 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 "TIGHTEN ASSEMBLY" OR "BLADE ERROR DETECTED" FOLLOWED BY A "REPLACE INSTRUMENT" SCREEN 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 ANTERIOR RESECTION PROCEDURE TWO HOURS INTO THE PROCEDURE THE DEVICE STOPPED WORKING PROPERLY. THE GEN04 STARTED MARKING "STRANGE NOISES" AND ERROR MESSAGE CAME UP. THE DEVICE WAS DISASSEMBLED AND THEN REASSEMBLED. DEVICE WAS THEN RE-TESTED OUTSIDE OF THE PATIENT AND AT THAT POINT THE ACTIVE BLADE FELL OFF. THE SURGEON WAS NOT AWARE OF HITTING ANY FOREIGN METAL OBJECT OR OF PUTTING EXCESS SIDE TRACTION ON THE INCIDENT BUT HE WAS BY NO MEANS CERTAIN. NO CONSEQUENCES FOR THE PATIENT. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88245 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE