BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3033098 · Received April 3, 2013

    Report

    Report Number
    3005075853-2013-01564
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 28, 2012
    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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE A WAS RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS FUNCTIONALLY TESTED ON THE GENERATOR AND THE DEVICE ACTIVATED WITH BOTH MAX AND MIN BUTTON. THE DEVICE WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS. CORROSION WAS FOUND AT THE HAND ACTIVATION DOMES. IT IS PROBABLE THAT THIS MAY HAVE AFFECTED THE FUNCTIONALITY OF THE HAND ACTIVATION BUTTONS. DEVICE B WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED AND THE BLADE COMPLETELY BROKE OFF DURING ANALYSIS. DEVICE C 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 DEVICES WERE FUNCTIONALLY TESTED WITH A GENERATOR. BOTH DEVICES ACTIVATED WITH BOTH MAX AND MIN BUTTONS. 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 DEVICES 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 ADDITIONAL INFORMATION: BATCH # J9233M, EXPIRATION DATE: 7/24/2017, MANUFACTURING DATE: 8/24/2012. DEVICE C ADDITIONAL INFORMATION: BATCH # G9KD1Z; EXPIRATION DATE: 5/16/2015; MANUFACTURING DATE: 6/16/2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY PROCEDURE, HAND ACTIVATION BUTTON WAS NOT WORKING PROPERLY. IT WORKED INTERMITTENTLY. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE. PROCEDURE WAS PROLONGED 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136342 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE