BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3232118 · Received July 17, 2013

    Report

    Report Number
    3005075853-2013-03599
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 MISSING AND WITH THE CLAMP ARM DETACHED BUT FIRMLY FIXED TO THE OUTER TUBE OF THE CLAMP ARM. THE REMAINING BLADE PORTION WAS SCRATCHED. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF OF THE DEVICE DURING TRANSPORT TO OUR ANALYSIS SITE. THE REPORTED COMPLAINT WAS FOR COULD NOT PASS TESTING. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON THE GEN11 GENERATOR, THE ¿INSTRUMENT ERROR¿ ALERT WAS DISPLAYED. A PROBABLE CAUSE OF THE DEVICE STOP ACTIVATING AND DISPLAY AN INSTRUMENT ERROR SCREEN IS BLADE DAMAGE. WHEN A BLADE IS DAMAGED, IT MAY NOT COMPLETE THE PRE-RUN TESTING, WILL DISPLAY AN ALERT MESSAGE. FOR GEN11 THIS SIGNAL IS ¿RELAX PRESSURE ON BLADE AND REACTIVE¿ TWICE FOLLOWED BY A ¿REPLACE INSTRUMENT¿, AND THE GENERATOR SYSTEM WILL REVERT TO STANDBY MODE. AT THAT POINT POWER OUTPUT STOPS IN A SAFE MODE PENDING TROUBLESHOOTING AND EVENTUAL DEVICE REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE THE DEVICE COULD NOT PASS TESTING. THE GENERATOR KEEPS ALARMING AND SHOWED "REPLACE INSTRUMENT.¿ PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331473 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE