BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION * SURG DEV, BLADES 5MM, ENDO

    MDR report key: 2821417 · Received November 6, 2012

    Report

    Report Number
    3005075853-2012-05043
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K990362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF. THE BROKEN PART OF THE BLADE WAS RECEIVED ALONG WITH THE INSTRUMENT. THE REMAINING BLADE PORTION IN THE DEVICE WAS SCRATCHED. INITIAL VISUAL INSPECTION REVEALED THE PRESENCE OF BODY FLUIDS, WHICH INDICATES THAT THE DEVICE WAS USED. DUE TO THE BLADE DAMAGE, THE DEVICE WAS CONFIRMED TO BE NON-FUNCTIONAL. 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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP HYSTEROMYOMA, AN ERROR 5 WAS DISPLAYED SOON. THE DEVICE CONTACTED WITH A CLAW-FORCEPS A FEW TIMES. WHEN THE DEVICE WAS PULLED OUT OUTSIDE THE PATIENT, THE ELECTRODE CAME OFF AND FELL ON THE FLOOR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FRAGMENTS WERE CONFIRMED INSIDE THE PATIENT ON X-RAY AND ON VIDEO OF THE PROCEDURE. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION * SURG DEV, BLADES 5MM, ENDO INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J91L6T

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE