BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 2872510 · Received December 13, 2012

    Report

    Report Number
    3005075853-2012-05712
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K112033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION THE INSTRUMENT WAS RECEIVED IN GOOD 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). THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. THE INSTRUMENT WAS TESTED ON TEST MEDIA AND PERFORMED AS EXPECTED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE INCIDENT REPORTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION RECEIVED: FROM SURGEON: IF THE DEVICE LOOKS FINE AT ANALYSIS, I SUSPECT THAT I JUST MISS FIRED IT. FROM REP: WHAT DIFFICULTY WAS THE SURGEON EXPERIENCING WHEN HAVING TROUBLE FIRING THE DEVICE? SURGEON WAS SQUEEZING AGAINST THE LOCKING MECHANISM. DID THE GEN11 DISPLAY ANY YELLOW ALERT SCREENS DURING THE PROCEDURE? UNKNOWN. DID THE SURGEON HEAR THE TONE CHANGES? YES. HOW LONG HAS THE SURGEON AND ACCOUNT BEEN USING THE GEN11? ONE YEAR. WAS THERE ANY BLOOD LOSS WHEN THE DEVICE DID NOT SEAL? YES. WHAT DID THE SURGEON DO WHEN THE DEVICE DID NOT SEAL? TRIED TO CONTROL BLEEDING WITH A SPONGE STICK. WHAT WAS THE RATIONALE FOR THE SURGEON OPENING THE PATIENT WITH THORACOTOMY? NEEDED TO CONTROL BLEEDING THAT HE WAS UNABLE TO CONTROL THORACOSCOPICALLY. WAS THE CONVERT TO THORACOTOMY A DIRECT RESULT OF THE A NEED TO CONTROL BLEEDING? YES. HOW MUCH BLOOD WAS LOST? (CC'S) 600. HOW WAS THE BLEEDING CONTROLLED IN THE 2ND PROCEDURE? UNKNOWN. WAS A TRANSFUSION REQUIRED? UNKNOWN. WAS THE PATIENT TAKING ANY ANTICOAGULANTS, SUCH AS ASPIRIN, ANTICOAGULANTS, OR ANTIPLATELET AGENTS)? IF YES, SPECIFY PRESCRIBED MEDICATION. UNKNOWN. HAS THE PATIENT UNDERGONE ANY RADIATION/CHEMOTHERAPY THERAPY? IF YES, PLEASE SPECIFY RADIATION, CHEMO, OR BOTH. UNKNOWN. DOES THE PATIENT HAS A KNOWN COAGULATION DISORDER? UNKNOWN. HAS THE PATIENT TAKEN ANY STEROIDS? UNKNOWN. WHAT WAS THE TOTAL BLOOD LOSS? SIX HUNDRED CC. WHAT WAS THE PATIENT'S PRE-OP HEMOGLOBIN AND HEMATOCRIT? UNKNOWN. WHAT WAS THE PATIENT'S POST OPERATIVE HEMOGLOBIN AND HEMATOCRIT? UNKNOWN. WHAT IS THE CURRENT PATIENT CONDITION? STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE VATS LOBECTOMY, THE SURGEON WAS TAKING A SMALL BRANCH OF THE PULMONARY ARTERY, APPROXIMATELY 2MM, AND HAD TROUBLE FIRING THE DEVICE. UPON FIRING, THE DEVICE DID NOT SEAL THE VESSEL. THE SURGEON OPENED THE PATIENT WITH THORACOTOMY AND COMPLETED THE CASE. VATS CASE TO OPEN THORACOTOMY WITH ADDITIONAL BLOOD LOSS. THE PATIENT IS STABLE. ONE DEVICE RETURNING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR