BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 STRAIGHT JAW

    MDR report key: 3981163 · Received August 5, 2014

    Report

    Report Number
    3005075853-2014-05478
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 8, 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
    JA
    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 UPPER TIP I BLADE BROKEN AND UPPER JAW DETACHED, BOTH PIECES RETURNED. THE DEVICE WAS CONNECTED TO THE GENERATOR AND IT WAS RECOGNIZED. BECAUSE THE JAW WAS DETACHED NOT ALL TESTING WAS PERFORMED WITH THE GENERATOR. AS REPORTED IN THE EVENT DESCRIPTION IT IS LIKELY THAT THE DAMAGE TO THE JAW AND I-BLADE WAS CAUSED BY NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT OR ATTEMPTING TO CUT THROUGH THICK DENSE TISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN OPEN PROCEDURE, THE BLADE WAS BROKEN OFF WHEN THE DEVICE WAS USED FOR A LIGAMENT AND THE BROKEN PIECE FELL INTO THE PATIENT. NO ERROR MESSAGE WAS DISPLAYED. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT WITH A FORCEPS. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457515 ENSEAL G2 STRAIGHT JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA K91T8X

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR