BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 ARTICULATING

    MDR report key: 4243369 · Received November 11, 2014

    Report

    Report Number
    3005075853-2014-07808
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 18, 2014
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE B WAS RECEIVED WITH THE SHAFT BENT. THE DEVICE WAS CONNECTED TO THE GENERATOR AND IT WAS RECOGNIZED. BECAUSE THE SHAFT WAS DAMAGED NOT ALL FUNCTIONAL TESTING COULD BE PERFORMED WITH THE GENERATOR AS THE BLADE DID NOT TRANSLATE AND THE JAWS COULD NOT CYCLE. IT IS POSSIBLE THAT THE DAMAGED SHAFT WAS DAMAGED DURING TRANSIT. IT WAS NOT A REPORTED ISSUE. NO CONCLUSION COULD BE REACHED AS TO HOW THE SHAFT GOT BENT, HOWEVER, IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ECTOPIC PROCEDURE, THE SURGEON USED TWO DEVICES. BOTH KEPT SHOWING ERROR ALERT "REPOSITION JAWS AND REACTIVATE". AFTER THIS HAPPENED SEVERAL TIMES, THE ERROR CODE "REPLACE INSTRUMENT" PRESENTED. CASE COMPLETED WITH A COMPETING DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726103 ENSEAL G2 ARTICULATING GEI ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR