BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2880047 · Received December 19, 2012

    Report

    Report Number
    3005075853-2012-05821
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. 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 THE JAWS NOT CLOSING COMPLETELY. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR AND DURING FUNCTIONAL TESTING THE JAWS OPENED AND CLOSED WITHOUT ANY ISSUES BUT THE GENERATOR DID DISPLAY AN ERROR CODE 5 (INSTRUMENT ERROR) DUE TO THE BROKEN BLADE. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 OR A SOLID TONE ON THE GENERATOR DISPLAY 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. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL THYROIDECTOMY PROCEDURE, THE SHEARS JAWS WERE NOT CLOSING COMPLETELY, WHEN THE TRIGGERS WERE PRESSED. SO, IT WAS NOT POSSIBLE TO ACTIVATE THE CUT AND THE COAGULATION. IT WAS NECESSARY TO REPLACE THE SHEARS BY ANOTHER ONE FROM THE SAME MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK H44T3L

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE