BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ELECTROSURGERY PROBE PLUS II

    MDR report key: 82087 · Received February 19, 1997

    Report

    Report Number
    1527736-1997-00168
    Event Type
    Malfunction
    Date Received
    February 19, 1997
    Date of Event
    January 22, 1997
    Report Date
    February 19, 1997
    Manufacturer
    EES-JUAREZ
    Product Code
    KNS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INQUIRY INFO RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS TESTED AND FUNCTIONED PROPERLY. THE ELECTRICAL COMPONENTS OF THE INSTRUMENT WERE EXAMINED AND NO DEFORMATIONS COULD BE FOUND. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY, IT WAS RPEORTED THE SURGEON RECEIVED AN ELECTRICAL SHOCK THROUGH CAUTERY BUTTON. ANOTHER INSTRUMENT WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 1/24/97 1000 SPOKE TO SURGEON WHO SAID HE WAS USING THE EPH04 DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE SURGEON SAID NEAR THE BEGINNING OF THE PROCEDURE HE RECEIVED AN ELECTRICAL SHOCK WHILE DEPRESSING THE CAUTERY BUTTON ON DEVICE. SURGEON REPORTED HE WAS ACTIVELY UTILIZING CAUTERY AT THE TIME TO DISSECT THE GALLBLADDER FROM THE LIVER WITH A HOOK ELECTRODE. SURGEON SAID HE COMPLETED THE PROCEDURE WITH ANOTHER EPH04. SURGEON SAID HE HAS USED THIS DEVICE EXTENSIVELY IN THE PAST AND HAS NOT EXPERIENCED THIS DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ELECTROSURGERY PROBE PLUS II ELECTROSURGERY KNS EES-JUAREZ NA J4404W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other