BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 2833140 · Received November 15, 2012

    Report

    Report Number
    3005075853-2012-05159
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT ADDITIONAL INFORMATION RECEIVED PER SALES REP: UPON SPEAKING TO MR (B)(6) HE FELT THAT THE DEVICE DID NOT SEAL THE VESSEL AS HE EXPECTED IT TO. I WAS NOT PRESENT FOR THE CASE AND ATTENDED AS SOON AS I LEARNED THAT THERE WAS A LAP CASE BEING PERFORMED AND FOR THE NEXT LAP CASE WHICH WAS SUBSEQUENTLY CANCELLED." THE SECOND(OPEN) PROCEDURE LASTED 90MINUTES IN TOTAL INCLUDING ANAESTHESIA. THE REP (MYSELF) WAS NOT PRESENT. SURGEON HAS USED ENSEAL THREE TIMES, AS SOON AS I HEAR THAT MR (B)(4) WAS USING THE DEVICE I ATTENDED THE HOSPITAL, THE PROCEDURE HAD BEEN COMPLETED WHEN I ARRIVED. I HAD PLANNED TO STAY FOR THE SECOND LAP PROCEDURE TO ENSURE ALL WAS WELL. I WAS TOLD THAT THE FIRST PROCEDURE WENT WELL, MR (B)(6) CHECKED ALL VESSELS AND LIGATION FOR BLEEDING PRIOR TO DISCHARGING PT FROM THEATRE AFTER THE LAP HEMI COLECTOMY - NO BLEEDING PRESENT. APPROX 30 MINS AFTER THE PROCEDURE, PT'S BLOOD PRESSURE PLUMMETED AND PT BECAME QUITE UNWELL, HE WAS RETURNED TO THEATRE AND AN OPEN PROCEDURE IDENTIFIED THE BLEEDING VESSEL. THE VESSEL WAS ONE OF THE EARLY LIGATIONS IN THE PROCEDURE. THE TISSUE WAS NORMAL. THERE WAS NO DEVICE WARNING. NO EXCESSIVE GRASP FORCE WAS USED. THE PATIENT HAD NOT HAD PRIOR SURGERY. THEY HAVE NOT HAD SIMILAR PROBLEMS WITH THIS MODEL OF ENSEAL PREVIOUSLY. THERE IS NO DAMAGE TO THE GEN11 VISIBLE. A TRANSFUSION WAS REQUIRED, 6 UNITS GIVEN. BLOOD LOSS WAS CONTROLLED BY PROCEEDING TO OPEN LAPAROTOMY AND LIGATION OF THE VESSEL. THE VESSEL WAS 3-5 MM IN SIZE. PATIENT IS A (B)(6) MALE . PATIENT IS RECOVERING WELL. I ALSO ASKED THE SURGEON WHETHER THE PATIENT WAS TAKING ANTI COAGULANTS AND HIS RESPONSE WAS " NO"

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A LEFT HEMICOLECTOMY PROCEDURE, THE DOCTOR CHECKED AN OBSERVED THAT THE OPERATING SITE WAS DRY THE PATIENT WAS DISCHARGED TO THE RECOVERY DEPARTMENT. SHORTLY AFTERWARDS, THE DOCTOR WAS INFORMED THAT HIS PATIENT'S BLOOD PRESSURE HAD DROPPED, THE PATIENT WAS RETURNED TO SURGERY IMMEDIATELY AND A LAPAROTOMY WAS PERFORMED. APPARENTLY THE IMA WAS BLEEDING. THE PROCEDURE WAS PROLONGED BY 90 MINUTES. THE DEVICE WAS DISCARDED.

    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 J4AT9V

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR GENERATOR AND HANDPIECE