BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 1983457 · Received February 10, 2011

    Report

    Report Number
    3005075853-2011-00537
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 29, 2011
    Report Date
    January 29, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS FOR 1 DEVICE, BUT THE ACCOUNT RETURNED 2 DEVICES. THE DEVICE A WAS RETURNED IN GOOD VISUAL CONDITION. THE BLADE WAS VISUALLY INSPECTED AND IT WAS IN GOOD PHYSICAL CONDITION AND NOT BROKEN IN ANY WAY. THE DEVICE WAS TESTED WITH A GENERATOR AND NO ERROR CODE WAS NOTED. HOWEVER, NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED, AS THE CLAMP ARM DID NOT CLOSE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND IT WAS NOTED THAT THE ROTATION KNOB WAS BROKEN AT THE PIN HOLE INTERFACE, NOT ALLOWING THE CLAMP ARM TO PROPERLY OPEN AND CLOSE. IN ADDITION, THE DAMAGE TO THE ROTATION KNOB AFFECTED THE INTERFACE BETWEEN THE HAND PIECE AND THE DEVICE. THE BROKEN ROTATION KNOB IS NOT RELATED TO THE REPORTED ISSUE OF "BLADE TIP BROKE OFF". 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. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TITANIUM TIP OF THE DEVICE WAS BROKEN. THE BROKEN PART DID NOT FALL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR 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 G4TT5E

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE