BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 1291104 · Received January 9, 2009

    Report

    Report Number
    1291104
    Event Type
    Malfunction
    Date Received
    January 9, 2009
    Date of Event
    January 8, 2009
    Report Date
    January 9, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    HARMONIC ACE CURVED SHEARS RECEIVED PAD DAMAGE DURING INTRAOPERATIVE USE - APPEARED MELTED. SURGERY WAS LAPAROSCOPIC SUPRA-CERVICAL HYSTERECTOMY. THE SALES REP WAS PRESENT AND TOOK THE DAMAGED PRODUCT.CLINICAL ENGINEERING WAS CALLED BY THE OR AND INFORMED THAT THE RETURN PLATE OF THE DISPOSABLE SHEARS HAD BEEN DAMAGED DURING THE CASE. THERE WASN'T ANY HARM, BUT THEY WANTED THE DEVICE CHECKED TO MAKE SURE IT IS WORKING PROPERLY. THE SALESMAN TOOK THE DAMAGED DISPOSABLE. HE RETRIEVED ALL 4 HAND CONTROLLERS BECAUSE THERE WASN'T ANY INDICATION AS TO WHICH WAS USED. COMPLETED SAFETY AND FUNCTIONAL TESTS OF THE GENERATOR AS PER MANUFACTURER'S SPECIFICATIONS. COMPLETED FUNCTIONAL TEST ON HAND CONTROLLERS. PHASE MARGIN (HZ)RANGE SHOULD BE BETWEEN 170-247. IMPEDANCE (ZR) RANGE SHOULD BE BETWEEN 15 - 40. NO ISSUES IDENTIFIED. ALL HAND CONTROLLERS WERE OPERATING WITHIN TOLERANCE. CLINICAL ENGINEERING CALLED THE ETHICON SALES REP. HE EXPLAINED THAT THE INCIDENT WAS CAUSED BY THE HAND CONTROLLER BEING ACTIVATED AFTER THE SHEARS HAD CUT THROUGH TISSUE CAUSING BOTH SIDES TO TOUCH. IF THIS HAPPENS THROUGHOUT THE CASE IT COULD HAVE CAUSED DAMAGE TO THE RETURN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE HARMONIC SHEARS LFL ETHICON ENDO-SURGERY, INC. ACE36E *

    Patients

    Seq Age Sex Outcome Treatment
    1 *