BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 STRAIGHT JAW

    MDR report key: 4521552 · Received February 17, 2015

    Report

    Report Number
    3005075853-2015-01122
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Report Date
    December 11, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K112033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS RECEIVED WITH THE TOP OF THE I-BLADE FRACTURED AND SLIGHTLY LIFTED. IN ADDITION THE UPPER JAW WAS DETACHED AND RETURNED, ALSO THE ENERGY BUTTON DETACHED AND RETURNED WITH THE INSTRUMENT. THE BUTTON WAS REATTACHED TO THE INSTRUMENT AND CONNECTED TO THE GEN11 AND IT WAS RECOGNIZED. BECAUSE OF THE CONDITION OF THE DEVICE NOT ALL FUNCTIONAL TESTING COULD BE PERFORMED WITH THE GENERATOR. THE CONDITION OF THE BLADE PREVENTED THE FUNCTIONALITY OF THE JAW. THE JAW COULD NOT BE HELD IN PLACE DUE TO THE BREAKAGE. A PROBABLE CAUSE OF THE DAMAGE TO THE I BLADE COULD BE NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE BUTTON DETACHED FROM THE INSTRUMENT IT SHOULD BE NOTED THAT OUR MANUFACTURING PROCESS VERIFIES THE PRESENCE AND FUNCTIONALITY OF THE INSTRUMENT PRIOR TO SHIPPING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMA PROCEDURE, THE JAW BROKEN AFTER A FEW TIMES; PART FELL INTO SITUS BUT COULD BE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114159 ENSEAL G2 STRAIGHT JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA L4EG4X

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR