BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 3972913 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05397
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 25, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. IT WAS FOUND THAT THE DEVICE WAS SLOW TO RETURN TO A FULLY OPEN POSITION. THIS COULD HAVE IMPACTED THE OPENING AND CLOSING PERFORMANCE OF THE DEVICE. THE DEVICE WAS TESTED ON THE GENERATOR AND PASSED ALL FUNCTIONAL TESTING. THE ENERGY OUTPUT DELIVERED FROM THE DEVICE WAS VERIFIED AND THE CUTTING OF THE TEST MEDIA PERFORMED AS EXPECTED. 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). OPENING AND CLOSING OF THE JAWS MULTIPLE TIMES PRIOR TO USE WILL REDUCE OR ELIMINATE THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. ADDITIONAL INFORMATION REQUESTED: DID THE SURGEON ATTEMPT TO MANUALLY OPEN THE JAWS WITH HIS FINGERS, IF NO: WAS THE DEVICE ON A VESSEL/ARTERY WHEN IT WOULD NOT OPEN, IF YES, HOW WAS THE DEVICE REMOVED, (I.E. CUT OFF, FORCED OPENED). IF CUT OFF, DID THIS CAUSE A CHANGE IN THE PLAN OF CARE FOR THE PATIENT. DID THE REMOVAL CAUSE ANY DAMAGE TO THE VESSEL/ARTERY, IF YES, WHAT IS THE DAMAGE AND HOW WAS THE DAMAGE REPAIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A LAPAROSCOPIC MYOMECTOMY PROCEDURE, THEY COULD NOT OPEN THE JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451144 ENSEAL G2 CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR