BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2935554 · Received January 30, 2013

    Report

    Report Number
    3005075853-2013-00386
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    November 12, 2012
    Report Date
    December 13, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF OF THE DEVICE DURING TRANSPORT TO OUR ANALYSIS SITE. THE REPORTED COMPLAINT WAS FOR THE ALERT SCREENS RELAX PRESSURE ON BLADE; REMOVE INSTRUMENT FROM PATIENT AND THE DEVICE NOT TESTING. THE DEVICE WAS FUNCTIONALLY TESTED ON THE GEN11 GENERATOR, THE 'INSTRUMENT ERROR' ALERT WAS DISPLAYED. THE DEVICE WILL STOP ACTIVATING, AND DISPLAY THE INSTRUMENT ERROR SCREEN TWICE FOLLOWED BY THE REPLACE INSTRUMENT SCREEN WHEN THE BLADE BECOMES DAMAGED. WHEN A BLADE HAS BEEN COMPROMISED SUCH AS SCRATCHED OR CRACKED, THE TITANIUM METAL IS FATIGUED WHEN CONTINUALLY ENERGIZED AND THIS RESULTS IN THE BLADE FURTHER CRACKING AND POSSIBLY BREAKING OFF. THOUGH WE DID NOT RECEIVE THE RELAX PRESSURE ON BLADE AND REMOVE INSTRUMENT FROM PATIENT ALERT SCREENS DURING FUNCTIONAL TESTING, THE 'RELAX PRESSURE ON BLADE; REACTIVE INSTRUMENT TO CONTINUE' YELLOW MESSAGE SCREEN IS ADVISING THAT THE INSTRUMENT HAS BEEN LOADED TO THE POINT WHERE OUTPUT HAS STOPPED. THE USER NEEDS TO RELAX PRESSURE ON THE INSTRUMENT OR REPOSITION SO THERE IS LESS TISSUE IN THE JAWS. RELEASE THE ACTIVATION SWITCH AND REACTIVATE THE INSTRUMENT TO CONTINUE. THE 'REMOVE INSTRUMENT FROM PATIENT' YELLOW MESSAGE SCREEN IS A PRELUDE TO FURTHER DIAGNOSTICS. TO AVOID INADVERTENT TISSUE DAMAGE DURING DIAGNOSTICS THE SURGEON IS GUIDED TO REMOVE THE INSTRUMENT FROM THE INCISION BEFORE PROCEEDING.

    Description of Event or Problem · 1

    MAUDE EVENT REPORT (B)(4) RECEIVED STATES THAT THAT DURING A UNKNOWN PROCEDURE, DEVICE TESTED FINE. IT WORKED FOR ABOUT FOUR MINUTES THEN IT STARTED TO BEEP 'RELAX GRIP.' THE DOCTOR REMOVED FROM PATIENT RELAXED GRIP AND THEN RETURNED TO USE. THIS HAPPENED THREE TO FOUR TIMES THEN THE LAST TIME THE MACHINE STATED THE INSTRUMENT WAS OUT OF PATIENT WHEN IT WAS NOT AND IT WOULD NOT EVEN TEST. THE MACHINE STATED 'ERROR.' OPENED A NEW HANDPIECE AND IT WORKED WITHOUT ISSUE. THE MEDWATCH RECEIVED INDICATES DEVICE IS AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41195 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE