BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 4346137 · Received December 19, 2014

    Report

    Report Number
    3005075853-2014-08868
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 13, 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
    EI
    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 JAWS BEING 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. IT IS POSSIBLE THAT DUE TO THE DAMAGE OF THE JAWS THE GENERATOR DISPLAYED AN ALERT SCREEN. HOWEVER THIS WAS NOT SEEN DURING THE ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ¿INSTRUMENT FAULT¿ KEPT SHOWING UP ON GENERATOR. THEY WERE ABOUT TO OPEN ANOTHER DEVICE AND THE SURGEON DECIDED SHE DIDN¿T NEED IT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838838 ENSEAL G2 CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA L4EEDI

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR