BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 2727277 · Received September 5, 2012

    Report

    Report Number
    3005075853-2012-04027
    Event Type
    Death
    Date Received
    September 5, 2012
    Date of Event
    July 18, 2012
    Report Date
    July 19, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. SURGEON PROVIDED ADDITIONAL INFORMATION: PATIENT WAS "BONE DRY WHEN HE LEFT OPERATING ROOM". PATIENT HAD BEEN RE-INSUFFLATED AND NO BLOOD WAS SEEN. PATIENT CODED IN RECOVERY ROOM 1 HR 15 MINUTES AFTER THE PROCEDURE. RE-OP FOUND BLEEDING FROM THE MAIN BRANCH OF ILEOCOLIC ARTERY. THIS ARTERY WAS SEALED WITH THE G2 TISSUE SEALER DURING THE ORIGINAL PROCEDURE. SURGEON SAID THAT PROBLEM (BLEEDING) WAS RELATED TO THE G2 TISSUE SEALER BUT COULD NOT SAY IF IT WAS DEVICE OR USE RELATED. ADDITIONAL INFORMATION FROM SALES REP: PATIENT AGE, COMORBIDITIES, CANCER STATUS, PRIOR RADIATION, PRE-OP STATUS, REASON FOR ORIGINAL OPERATION? I DO NOT KNOW. IS THIS SURGEON A NEW ENSEAL USER? DID HE PREVIOUSLY USE LEGACY DEVICES OR A COMPETITIVE DEVICE? HE HAS BEEN USING G2 SUPER JAW. THIS WAS HIS FIRST CASE WITH (B)(4). HOW MANY TIMES USED THE G2 TISSUE SEALER, NOTICE ANYTHING STRANGE ABOUT THIS DEVICE? FIRST TIME, DID NOT NOTICE ANYTHING STRANGE. DURING RE-OP WAS BLEEDING COMING FROM ANYPLACE SPECIFIC? I WAS NOT IN RE-OP CASE. WHAT TYPE OF HEMICOLECTOMY? RIGHT, LEFT? RIGHT. WHAT INPUTS/CRITERIA DID THE SURGEON USE TO ADVANCE THE I-BLADE? (EX. FORCE, TONES, VISUAL, TIME). HE USED TONES AND HIS KNOWLEDGE OF ENSEAL TECHNOLOGY. WERE YOU PRESENT FOR THE PROCEDURE? YES. DURING THE INITIAL PROCEDURE, WAS THERE ANY BLEEDING FROM AN AREA THAT THE NSLG2C35 WAS USED ON? I DID NOT OBSERVE BLEEDING. WAS THERE ANY BLEEDING FROM AN AREA THAT THE NSLG2C35 WAS USED ON DURING THE PROCEDURE? I DID NOT OBSERVE BLEEDING. WAS THE TISSUE THICK, DENSE AND FIBROUS? DO NOT KNOW. WAS EXCESSIVE GRASPING FORCE USED? I DID NOT OBSERVE EXCESSIVE GRASPING FORCE WHAT OTHER INSTRUMENTS WERE USED DURING THE INITIAL SURGERY? I DO NOT KNOW. HOW WAS IT DETERMINED THAT THE G2 TISSUE SEALER CAUSED THE BLEEDING AND NOT THE STAPLER OR OTHER INSTRUMENTS? IT WAS NOT STATED THAT G2 TISSUE SEALER CAUSED THE BLEEDING IN MY CONVERSATION WITH THE SURGEON AND HIS PARTNER AFTER THE CASE. WHEN THE PATIENT RETURNED TO THE OPERATING ROOM, HOW WAS THE BLEEDING CONTROLLED? DO NOT KNOW. HOW MUCH BLOOD WAS LOST? DO NOT KNOW. WAS A TRANSFUSION REQUIRED? DO NOT KNOW. HOW LONG HAS THE SURGEON AND ACCOUNT BEEN USING THE GEN11? 6 MONTHS +. WAS THERE ANY ISSUES WITH THE USE OF THE DEVICE DURING THE PROCEDURE? NO. DID THE SURGEON HEAR THE TONE CHANGES? YES HE HEARD TONE CHANGES. SURGEON HAS BEEN USING G2 SUPERJAW AND IS AWARE OF TONES. ON WHAT DATE DID THE PATIENT DIE? (SAME DAY, NEXT DAY?) SAME DAY. WAS AN AUTOPSY PERFORMED? IF YES, WHAT WAS CAUSE OF DEATH INDICATED IN REPORT? DO NOT KNOW. CAN WE OBTAIN A COPY OF THE AUTOPSY REPORT? DO NOT KNOW. IF NO AUTOPSY WAS DONE/WILL BE DONE, IS THE HOSPITAL ATTRIBUTING THE PATIENT'S DEATH TO THE (B)(4) FAILURE? NOT TO MY KNOWLEDGE. IF YES, PLEASE EXPLAIN HOW THEY ARRIVE AT THIS CONCLUSION? IF NOT, WHAT OTHER PATIENT FACTORS/EVENTS LED TO THE BLEEDING? DO NOT KNOW. DO NOT KNOW ANY PATIENT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEMICOLECTOMY PROCEDURE, THE SURGEON USED THE DEVICE ACCORDING TO INSTRUCTION FOR USE AND WITHOUT COMPLICATION. THE BOWEL WAS MOBILIZED AND THE ANASTOMOSIS COMPLETED WITH THE STAPLER EXTRACORPOREAL. THE PATIENT WAS CLOSED; THEY REALIZED SHE WAS BLEEDING IN RECOVERY. THE PATIENT WAS TAKEN BACK TO RE-OP TO CONTROL THE BLEEDING. THE BLEEDING WAS CONTROLLED; THE PATIENT WENT TO RECOVERY. THE PATIENT LATER EXPIRED. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death GENERATOR