BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS* CURVED SHEAR 17CM

    MDR report key: 3211484 · Received July 8, 2013

    Report

    Report Number
    3005075853-2013-03436
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K063192
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS TESTED ON GENERATOR AND IT WAS FOUND THAT THE MAX AND MIN HAND CONTROL SWITCH ASSEMBLY BUTTONS WERE NOT FUNCTIONAL. HOWEVER, IT WORKED PROPERLY WITH FOOT SWITCH ASSEMBLY. NO CONTINUOUS ACTIVATION WAS NOTED DURING TESTING. THE INSTRUMENT WAS DISASSEMBLED AND DAMAGED WAS FOUND TO THE FLEXIBLE CIRCUIT, IN THE FORM OF CORROSION UNDER THE SWITCH DOME ASSEMBLY OF BOTH THE MAX AND MIN BUTTONS. THIS CAUSED THE NON-ACTIVATION OF THE BUTTONS. THE CORROSION IN THE DOMES IS POSSIBLY CAUSED WHEN THE DEVICE WAS SOAKED FOR RE-USE; THE INTRODUCTION OF SALINE OR BLOOD GETTING UP INTO THE DEVICE DURING THE PROCEDURE, OR THE DEVICE BEING SOAKED FOR CLEANING BEFORE SHIPMENT FOR ANALYSIS. IT IS PROBABLE THAT THIS MAY HAVE AFFECTED THE FUNCTIONALITY OF THE HAND ACTIVATION BUTTONS.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY, AN ACTUATION SOUND WAS HEARD WITHOUT PUSHING ANY BUTTON ON THE MAYO STAND AT THE END OF THE OPERATION. THE DEVICE STOPPED BEING USED, AN ACTUATION SOUND CONTINUED INTERMITTENTLY UNTIL THE GENERATOR WAS TURNED OFF. THE DEVICE WAS USED FOR THE BLOOD VESSEL. ANOTHER DEVICE WAS NOT USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310750 HARMONIC FOCUS* CURVED SHEAR 17CM INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE