BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 ARTICULATING

    MDR report key: 4177193 · Received October 16, 2014

    Report

    Report Number
    3005075853-2014-07118
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 2, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. DEVICE EVALUATION - NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE JAW BROKE ON THE ENSEAL INSTRUMENT DURING AN UNKNOWN CASE. A SECOND INSTRUMENT WAS USED TO COMPLETE THE CASE WITH NO CONSEQUENCE TO THE PATIENT. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657633 ENSEAL G2 ARTICULATING . GEI ETHICON ENDO-SURGERY, LLC. NA L4EX13

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE