BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 5230387 · Received November 17, 2015

    Report

    Report Number
    3005075853-2015-07440
    Event Type
    Death
    Date Received
    November 17, 2015
    Date of Event
    October 28, 2015
    Report Date
    November 10, 2015
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECEIVED INFORMATION FROM HOSPITAL RISK MANAGEMENT: PEER REVIEW OCCURRED YESTERDAY NOVEMBER 30, 2015. PHYSICIAN DID NOT FEEL LIKE THERE WAS ANY ISSUE WITH THE ENSEAL. HAD NEVER HAD A PROBLEM WITH THE DEVICE. DID NOT HAVE AN ANSWER AS TO WHAT OCCURRED. ENSEAL USED THROUGH THE SURGERY. OTHER VESSELS DID NOT FAIL. CHRONIC/HIGH STEROID USE BY PATIENT WAS A PRE-EXISTING CONDITION. PEER REVIEW FOCUSING ON PACU CARE AT THIS POINT. PEER REVIEW MADE THE DECISION THAT THE DEATH IS NOT BEING ATTRIBUTED TO THE DEVICE. BLEEDING A RISK TO THIS KIND OF PROCEDURE. DEATH DUE TO THE BLEEDING BUT MORE A KNOWN COMPLICATION. TOP TRAUMA SURGEON IS PART OF THE REVIEW PROCESS. POST OP CARE IS BEING LOOKED AT, NOT A SURGICAL ISSUE. BASED ON THIS INFORMATION, THIS EVENT IS NO LONGER REPORTABLE.

    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 FROM SALES REP: SURGEON ADVISED THAT HE USED THE DEVICE FOR ENTIRE PROCEDURE AND THERE WAS NO FAILURE OF THE DEVICE (THOUGH IT IS UNKNOWN IF THE DEVICE FAILED TO SEAL THE VESSEL). PATIENT WAS UNDER THE CARE OF PACU FOR 4 HR 20 MINUTES AFTER INITIAL PROCEDURE BEFORE BEING RETURNED TO THE OR. BLOOD LOSS WAS MASSIVE. A THIRD PROCEDURE WAS DONE AS PATIENT HAD COMPARTMENT SYNDROME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 HOURS AND 20 MINUTES POST OP OF A LAPAROSCOPIC SLEEVE GASTRECTOMY, THAT PATIENT WAS RETURNED TO THE OPERATING ROOM DUE TO BLEEDING. THERE WAS NO REPORTED BLEEDING DURING THE PROCEDURE. DURING SURGERY, THE SURGEON BIOPSIED THE LIVER. PATIENT HAD NON ALCOHOLIC STEATOHEPATITIS, PATIENT WAS HYPERTENSIVE, UNABLE TO GET A HEMOGLOBIN UNTIL THEY WERE IN THE OPERATING ROOM, PATIENT HAD AN ARRHYTHMIA DURING SURGERY. PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE SURGEON INSERTED TROCARS AND FOUND MASSIVE BLOOD LOSS, PATIENT WAS COAGULOPATHIC AND AS THEY WERE SUCTIONING OUT THE BLOOD THEY FOUND A SMALL ARTERIAL VESSEL PUMPING ALONG THE SPLENIC HILUM (SHORT GASTRICS). THE SURGEON COMPLETED THE SECOND OPERATION, PATIENT STARTED TO EXPERIENCE RENAL, LUNG, AND HEART FAILURE. PATIENT WAS ACIDOTIC AND LATER EXSANGUINATED. SURGEON DOESN'T KNOW IF ISSUE WAS RELATED TO THE PATIENT'S TISSUE, USER ERROR, OR INSTRUMENT FAILURE. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759409 ENSEAL G2 CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death