BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1960879 · Received January 14, 2011

    Report

    Report Number
    3005075853-2011-00170
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 24, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDED ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS. 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 AN UNKNOWN PROCEDURE AN ERROR CODE 5 WAS RECEIVED. THE SURGEON THEN TESTED THE SCALPEL AND THE TITANIUM TIP WAS BROKEN WHEN SELF-TESTED. THE BROKEN PART DID NOT FALL INTO THE PATIENT. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK G4TF7U

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE