BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 ARTICULATING

    MDR report key: 4243565 · Received November 11, 2014

    Report

    Report Number
    3005075853-2014-07819
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 1, 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
    NY, 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 WAS RECEIVED WITH THE JAWS FULLY CLOSED. THE DEVICES WAS MECHANICAL TESTED AND IT WAS NOTED THAT JAWS COULD NOT BE OPENED AND THE I BLADE DID NOT TRANSLATE WHEN THE TRIGGER WAS FIRED. THE DEVICE WAS CONNECTED TO THE GENERATOR AND IT WAS RECOGNIZED. DUE TO THE JAWS AND THE I BLADE CONDITION NOT ALL FUNCTIONAL TESTING COULD BE PERFORMED WITH THE GENERATOR. THE DAMAGED FOUND IN JAWS COULD CAUSE THE INABILITY TO OPEN AND CLOSE THE JAWS DUE TO THE DAMAGED OF THE INTERNAL COMPONENTS IN SHAFT. NO CONCLUSION COULD BE REACH AS HOW THIS DAMAGE OCCURS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE DOCTOR REPORTED THAT THE DEVICE WAS STICKING AT THE VERY BEGINNING OF THE CASE. THE JAWS WERE DIFFICULT TO OPEN AND CLOSE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727470 ENSEAL G2 ARTICULATING . GEI ETHICON ENDO-SURGERY, LLC. NA L4EX1E

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE