BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1971335 · Received January 27, 2011

    Report

    Report Number
    3005075853-2011-00320
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE A WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED. DURING FUNCTIONAL TESTING, AN ERROR CODE 5 WAS AND THE BLADE TIP BROKE OFF. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 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. A PROBABLE CAUSE OF AN ERROR CODE 5 (INSTRUMENT ERROR) IS BLADE DAMAGE. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE. DEVICE B WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED. THE DEVICE WAS ACTIVATED WITH THE GENERATOR AND AN ERROR CODE 5 WAS DISPLAYED. 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 AN ERROR CODE 5 OR BLADE "LOCKOUT" LATER IN THE PROCEDURE, AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE. DEVICE C WAS RECEIVED WITH THE BLADE BROKEN OFF AND MISSING. THE LOCATION OF THE BREAK IS INSIDE THE TUBE PROXIMAL TO THE TISSUE PAD. DURING FUNCTIONAL TESTING ON A GENERATOR THE DEVICE GAVE AN ERROR CODE 5. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 ON THE GENERATOR DISPLAY WHEN THE BLADE BECOMES DAMAGED. THE ANALYSIS CONCLUDED THAT THE BLADE BROKE DUE TO CONTACT WITH THE INNER TUBE. THIS DAMAGE WAS MOST LIKELY DUE TO EXCESSIVE SIDE FORCES APPLIED TO THE BLADE WHILE ACTIVATING RESULTING IN BLADE CONTACT WITH THE...

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS THAT DURING A MYOMECTOMY PROCEDURE THE SURGEON USED THREE DEVICES DURING THE CASE. TWO OF THE DEVICES HAD BROKEN BLADES THAT WERE FOUND AFTER A SOLID TONE AND AN UNKNOWN ERROR CODE ON THE PATIENT'S ABDOMEN, THE THIRD DEVICE STOPPED ACTIVATION WITH NO ERROR CODES. THEY COMPLETED THE PROCEDURE WITH A FOURTH NEW LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED- NO PIECES FELL INTO THE PATIENT. THE THREE DEVICES WILL BE RETURNING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK G9LG85

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE