BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1911421 · Received December 1, 2010

    Report

    Report Number
    3005075853-2010-06764
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 25, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE 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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT STATUS POST PLATE AND SCREW IMPLANTATION HEARD A SNAP IN THE JAW AND RETURNED TO SURGEON. THE FIRST X-RAY SURGEON COULD NOT TELL IF PLATE WAS BROKEN; PT RETURNED ONE WEEK LATER AND AN X-RAY SHOWED THE PLATE WAS BROKEN. SURGEON REMOVED THE PLATE AND REVISED THE PT TO ANOTHER PLATE, PT WOULD NOT ALLOW USE OF BONE GRAFT. SURGEON NOTED PREVIOUS SURGERY NO BONE GRAFT WAS USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE, THE HARMONIC PROBE'S ACTIVE BLADE WAS BROKEN. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE