BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 3142679 · Received June 3, 2013

    Report

    Report Number
    3005075853-2013-02734
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    February 1, 2013
    Report Date
    May 21, 2013
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. THE DEVICES 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). NO SPARKS WERE NOTED DURING TESTING. NO ISSUES WERE NOTED WITH OPENING AND CLOSING OF THE JAWS. IT IS POSSIBLE THAT EXCESSIVE BODY FLUIDS INFLUENCE THE OPENING AND CLOSING OF THE JAWS. THE ACCUMULATION OF BODY FLUIDS IS A ROUTINE OCCURRENCE DURING SURGICAL PROCEDURES AND DOES NOT NECESSARILY INDICATE A MANUFACTURING DEFECT IN THE DEVICE. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN CYSTECTOMY PROCEDURE, TOWARDS THE END OF THE CASE THE SURGEON USED THE DEVICE TO SEAL A VESSEL WITHIN THE BLADDER PEDICLE: THE I-BLADE WOULD NOT RETRACT AND SUBSEQUENTLY THE JAWS WOULDN¿T OPEN FOLLOWING THE ACTIVATION. THE DEVICE WAS OPENED WITH FORCE VIA THE HANDLE. LATER ON IN THE PROCEDURE DURING THE MOBILIZATION OF THE SMALL BOWEL MESENTERY TO CREATE THE BLADDER THE DEVICE BEGAN SPARKING. THE INSTRUMENT WAS NOT USED AGAIN IN THE PROCEDURE. CLIPS WERE USED IN THE SAME PROCEDURE. THE SURGEON DOES NOT FEEL THESE WERE IN VERY CLOSE PROXIMITY TO THE INSTRUMENT TIP. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244932 ENSEAL G2 CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR