BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2002661 · Received February 28, 2011

    Report

    Report Number
    3005075853-2011-00764
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 14, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND RETURNED WITH THE DEVICE. THE DEVICE WAS VISUALLY INSPECTED AND IT CONTAINED BODY FLUIDS, EVIDENCE OF USE ON THE PATIENT. THE COMPLAINT ADVISED THAT "WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE BLADE WAS BROKEN." AS THE DEVICE CONTAINED BODY FLUIDS, THIS IS EVIDENCE THAT THE BLADE HAD BEEN USED AND DAMAGED AND WAS OUT BROKEN INSIDE THE STERILE PACKAGING. 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 THE HARMONIC BLADES ARE MADE OF TITANIUM. THE HARMONIC BLADE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE AND/OR DISPLAY AN INSTRUMENT ERROR CODE WHEN THE BLADE HAS BECOME CRACKED (BUT NOT SCRATCHED, NICKED OR GOUGED). ONCE THE BLADE IS CRACKED, IT IS SUSCEPTIBLE TO BREAKING OFF DUE TO CONTINUED ATTEMPTS TO ACTIVATE OR FROM PHYSICAL CONTACT. ONCE THE BLADE TIP IS BROKEN OFF, IT MAY BE POSSIBLE FOR THE DEVICE TO BE ACTIVATED WITHOUT AN ERROR CODE. BLADE DAMAGE IS CAUSED BY CONTACTING AN ACTIVE BLADE WITH OTHER SURGICAL DEVICES, STAPLES OR CLIPS DURING THE PROCEDURE OR USING ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE BLADE. ONCE BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY RESULT IN FATIGUE FAILURE INITIATING AT THE ORIGINAL DAMAGE LOCATION, WHICH CAN RESULT IN THE BLADE TIP BREAKING OFF AS DESCRIBED ABOVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE BLADE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE