BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 STRAIGHT JAW

    MDR report key: 3812255 · Received May 15, 2014

    Report

    Report Number
    3005075853-2014-03269
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 18, 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
    CA, 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 TOP OF THE I-BLADE BROKEN OFF NOT RETURNED. IN ADDITION THE UPPER WAS DETACHED RETURNED. THE DEVICE WAS CONNECTED TO THE GENERATOR AND IT WAS RECOGNIZED. BECAUSE OF THE DAMAGE TO THE DEVICE NOT ALL TESTING WAS PERFORMED WITH THE GENERATOR. THE CONDITION OF THE DEVICE PREVENTED THE FUNCTIONALITY OF THE JAW. THE JAW WAS UNABLE TO CYCLE OPEN AND CLOSE. THERE IS INSUFFICIENT EVIDENCE RELATED TO WHAT CAUSED THE DAMAGE; 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA MESH REPLACEMENT PROCEDURE, THE SURGEON BROKE THE TOP JAW ON TWO SEPARATE DEVICES; ONE JAW ACTUALLY CAME OFF AND FELL INTO THE PATIENT. IT WAS SUCCESSFULLY RETRIEVED. A THIRD ENSEAL DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291758 ENSEAL G2 STRAIGHT JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR