BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 ARTICULATING

    MDR report key: 6556925 · Received May 10, 2017

    Report

    Report Number
    3005075853-2017-02491
    Event Type
    Malfunction
    Date Received
    May 10, 2017
    Date of Event
    April 4, 2017
    Report Date
    April 4, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K122797
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH P91009. THE DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. TESTING FOUND A SHORT ON THE DEVICE WHEN THE JAWS ARE FULLY CLOSED, RESULTING IN AN ALERT SCREEN "REPOSITION JAWS AND REACTIVE", THIS IS ADVISING THAT THE INSTRUMENT IS BEING ACTIVATED ON LOW IMPEDANCE (THIN) TISSUE OR METAL (SUCH AS STAPLES, CLIPS, RETRACTORS, OR CLAMPS), THE "REPLACE INSTRUMENT" ALERT SCREEN WOULD BE DISPLAYED AFTER RECEIVING THE "REPOSITION AND REACTIVATE" ALERT SCREEN TWICE. THE DEVICE WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS. IT WAS FOUND THAT AN INTERNAL COMPONENT WAS MISASSEMBLED, AFFECTING THE FUNCTIONALITY OF THE DEVICE. IT IS LIKELY THAT THIS ISSUE OCCUR DURING OUR MANUFACTURING PROCESS. THE BATCH HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE JUST STOPPED WORKING. ANOTHER DEVICE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337486 ENSEAL G2 ARTICULATING ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA P9122H

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR