BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 4213578 · Received October 30, 2014

    Report

    Report Number
    3005075853-2014-07486
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 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
    OH, 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 IN GOOD VISUAL CONDITION. UPON VISUAL INSPECTION UNDER MAGNIFICATION IT WAS NOTICED THAT THE UPPER JAW WAS SLIGHTLY DAMAGED AT THE RETENTION PIN INTERPHASE. RESULTING IN THE JAW BEEN LOOSE AND DIFFICULTY IN OPENING AND CLOSING OF THE JAWS. HOWEVER THE DAMAGE WAS NOT SIGNIFICANT ENOUGH TO IMPEDE THE DEVICE FUNCTIONALITY. THE DEVICES WAS TESTED ON THE GENERATOR AND PASSED ALL FUNCTIONAL TESTING. THE ENERGY OUTPUT DELIVERED FROM THE DEVICE WAS VERIFIED. ALL THREE TONES WERE HEARD DURING FUNCTIONAL TESTING (TONE 1 IS HEARD WHEN THE ENERGY ACTIVATION BUTTON IS PRESSED; TONE 2 IS HEARD WHEN TISSUE IMPEDANCE THRESHOLD IS REACHED; AND TONE 3 IS HEARD WHEN THE CYCLE IS COMPLETE). A PROBABLE CAUSE OF THE DAMAGE TO THE JAW 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 AN UNKNOWN SURGERY THE JAW COULD NOT CLOSE OR SLIDE PROPERLY. A SECOND DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694996 ENSEAL G2 CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA K4EM9F

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR