BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2133599 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02485
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 27, 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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, AN ERROR 5 WAS DISPLAYED AND THE BLADE WAS BROKEN OFF AT THE SYSTEM CHECK. THE SYSTEM CHECK WAS PERFORMED IN CLOSING THE CLAMP ARM. AS THE BLADE WAS BROKEN OFF OUTSIDE THE PATIENT, NO PIECES WERE LEFT INSIDE THE PATIENT'S BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE CUSTOMER DISPOSED OF THE DEVICE. INSTRUCTIONS FOR USE ADVISE: FOR PRE-RUN TESTING (SYSTEM CHECK) PLACE THE GENERATOR IN READY MODE BY DEPRESSING THE STANDBY BUTTON. HOLD THE INSTRUMENT IN THE AIR (IF COAGULATING SHEARS ARE USED, OPEN THE CLAMP ARM) AND DEPRESS THE MIN OR MAX POWER LEVEL ON THE FOOT SWITCH OR HAND SWITCHING ADAPTOR. "TEST IN PROGRESS" WILL APPEAR ON THE GRAPHIC DISPLAY AND A RAPID TWO-TONE PULSE WILL SOUND WHILE THE TEST IS OCCURRING. DURING THIS FIVE-SECOND PERIOD, A SYSTEM CHECK IS BEING PERFORMED.

    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