BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 3915566 · Received July 7, 2014

    Report

    Report Number
    3005075853-2014-04673
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 1, 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). ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. DURING FUNCTIONAL TESTING, 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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 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 DOCTOR WAS PERFORMING A LAPAROSCOPIC RIGHT COLECTOMY WITH THE ENSEAL DEVICE AND THE JAWS WOULDN'T OPEN AFTER SEALING THE TISSUE. THE DOCTOR HAD TO MANUALLY OPEN THE JAWS OF THE DEVICE. THE DOCTOR TRIED USING THE DEVICE A SECOND TIME AND HAD TO MANUALLY OPEN THE JAWS OF THE DEVICE AFTER SEALING THE TISSUE. NO VESSELS WERE ENCOUNTERED WHEN USING THE DEVICE. A SECOND DEVICE WAS USED TO COMPLETE THE CASE WITH NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393508 ENSEAL G2 CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA K4CL7K

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR