BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1854907 · Received October 5, 2010

    Report

    Report Number
    3005075853-2010-05690
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 16, 2010
    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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS SHOWED THAT THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP ABLATION OF ENDOMETRIOSIS THE HARMONIC SHEARS WAS ATTACHED TO THE HANDPIECE AND TESTED. ALL TESTS PASSED. THREE FOURTH WAY THROUGH THE PROCEDURE THE GEN GAVE A LONG TONE ON BOTH THE MAX AND MIN BUTTONS. I ASKED THE SCRUB SISTER TO CLEAN THE JAWS OF THE INSTRUMENT, TO SWITCH IT IN WATER, THE DEVICE WAS TESTED AGAIN AND THE GEN GAVE A INSTRUMENT ERROR. THE INSTRUMENT WAS REMOVED FROM THE HANDPIECE AND THE BLADE CLEANED, IT THEN BROKE. ANOTHER STERILE DEVICE WAS OPENED TO COMPLETE THE SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE PHYSICIAN WAS TREATING AN 85% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN WANTED TO USE THIS 3.5X8MM QUANTUM MAVERICK BALLOON CATHETER TO POST-DILATE A STENT. DURING INSERTION, THE SHAFT OF THE CATHETER WAS NOTED TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE