BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2061787 · Received April 19, 2011

    Report

    Report Number
    3005075853-2011-01563
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 7, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS CONFIRMED THAT THE DEVICE WAS RETURNED WITH THE OUTER TUBE BENT (AS THE CUSTOMER ADVISED THAT THE SHAFT WAS BENT WHILE PACKAGING THE DEVICE FOR SHIPMENT). THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL. THE CUTTING OF THE TEST MEDIA PERFORMED AS EXPECTED. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN LAPAROSCOPIC TOTAL GASTRECTOMY PROCEDURE, THE DOCTOR FELT THAT IT HAD A DIFFICULTY IN COAGULATION WHEN THE DEVICE WAS USED FOR THE BLOOD VESSEL AND BLEEDING OCCURRED. THE AMOUNT OF THE BLEEDING WAS 135 ML. NO ERROR CODE WAS DISPLAYED. THE TRIGGER WAS GRASPED TILL THE CLICK SOUND WHICH WOULD BE HEARD WHEN THE TRIGGER WOULD BE GRASPED PROPERLY. THE MIN BUTTON WAS USED MAINLY AT THE OPERATION. THE POWER SETTING OF THE MIN BUTTON WAS CHANGED FROM 3 TO 1 DURING THE OPERATION AND THE DEVICE WAS USED CAREFULLY. THE SHAFT WAS BENT AS IT WAS PRESSED IN THE DISCARDED BOX AFTER THE OPERATION. BIPOLAR WAS USED BY HEMOSTASIS. BLOOD TRANSFUSION WAS NOT PERFORMED AND THE OPERATION WAS NOT CONVERTED TO OPEN. THE PATIENT CONDITION WAS GOOD AND THERE WERE NO ADVERSE CONSEQUENCES TO 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE