BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENSEAL G2 STRAIGHT JAW

    MDR report key: 5498823 · Received March 14, 2016

    Report

    Report Number
    3005075853-2016-01434
    Event Type
    Death
    Date Received
    March 14, 2016
    Date of Event
    February 11, 2016
    Report Date
    February 18, 2016
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION ASKED AND OBTAINED: NON- IDENTIFYING PATIENT INFORMATION - AGE, WEIGHT, HEIGHT AND PRE-EXISTING MEDICAL CONDITIONS: PATIENT IS FEMALE BETWEEN 50-60 ¿ BMI IS AVERAGE. PLEASE QUANTIFY THE AMOUNT OF BLOOD THE PATIENT LOST DURING THE PROCEDURE. LOSS OF BLOOD WAS 1000 ML. DID THE PATIENT REQUIRE A TRANSFUSION DURING THE PROCEDURE; IF SO, HOW MUCH BLOOD WAS TRANSFUSED. NO TRANSFUSION WAS GIVEN. WHAT WAS THE REASON FOR THE PANCREATECTOMY, WHAT WAS THE PREOPERATIVE DIAGNOSIS: THE PRE-OPERATIVE DIAGNOSIS WAS A 4CM CYST, WHICH ONCE RUPTURED, LOW VOLUME. REGARDING THE POSTPANCREATECTOMY HEMORRHAGE, HOW MANY HOURS POST-OP WAS THE DECISION TO RE-OPERATE MADE AND WERE THERE ANY OTHER INDICATIONS OF BLEEDING PRIOR TO THE DEVELOPMENT OF SHOCK: NO HYPOTENSION OR SHOCK DURING THE PROCEDURE. WHERE WAS THE SECOND ENSEAL DEVICE USED (WHAT STRUCTURES): IT WAS MAINLY USED FOR DISSECTION AND EXPOSURE ON LITTLE VASCULARIZED STRUCTURES. DOES THE SURGEON/ACCOUNT UNDERSTAND THE ALERT SCREENS AND WHAT TROUBLESHOOTING STEPS ARE REQUIRED: THE SURGEON IS AN EXPERIENCED USER OF ENSEAL, HAS BEEN USING FOR OVER A YEAR IN A UNIVERSITY/HOSPITAL SETTING. AS WELL HE WENT TO (B)(6) FOR TRAINING. THIS IS BEING ASKED BECAUSE THE EVENT STATES: DEVICE #1 ¿ HAD MULTIPLE ERROR CODES, SUCH AS REPLACE INSTRUMENT, ETC. THEY UNPLUGGED AND RE-PLUGGED IN THE DEVICE. THE GENERATOR ADVISED THAT THE DEVICE NEED TO BE REPLACED, NOT TO UNPLUG AND RE-PLUG BACK INTO THE GENERATOR. WHY WAS THE DEVICE NOT REPLACED AT THAT TIME: THERE WERE A NUMBER OF ERROR CODES GIVEN BY THE GEN11. AT LEASE 3X, THE ENSEAL SHEAR HAD TO BE DISCONNECTED AND RECONNECTED. EACH TIME AFTER FOLLOWING RECONNECTION THE TONES WERE HEARD AND AN EFFECT ON THE TISSUE COULD BE SEEN. WHEN APPLICATION OF THE ENSEAL WAS DONE ON THE SPLENIC VEIN, OR A BRANCH OF THE VEIN OCCURRED. THE SURGICAL PLANE SEEMED AVASCULAR. ON REMOVING THE DEVICE, THERE WAS BLEEDING. THEY WANTED TO CONTROL THE BLEEDING WITH THE ENSEAL; THE DEVICE COMPLETELY STOPPED WORKING (NO TONES HEARD, NO EFFECT ON TISSUE). A NEW DEVICE WAS OPENED AND USE, AND IT WORKED NORMALLY (TONES HEARD AND THERE WAS AN EFFECT ON TISSUES). THE BLEEDING COULD NOT BE CONTROLLED WITH THE ENSEAL, THEY HAD TO USE CLIPS AND THEN ULTIMATELY STAPLER ¿ NEITHER OF THESE WERE J&J DEVICES. THE BLEEDING WAS CONTROLLED WITH STAPLES. THE 2ND SHEAR WAS USED FROM THE REMAINDER OF THE PROCEDURE, AND BEHAVED NORMALLY. ALL INSTRUMENTS WERE DISCARDED AFTERWARDS. WAS AN AUTOPSY PERFORMED; IF YES, WHAT WAS CAUSE OF DEATH INDICATED IN REPORT: PATHOLOGY REPORT IS NOT YET AVAILABLE. IF NO AUTOPSY WAS DONE, IS THE HOSPITAL ATTRIBUTING THE PATIENT'S DEATH TO THE NSLG2S35 FAILURE; IF YES, PLEASE EXPLAIN HOW THEY ARRIVE AT THIS CONCLUSION: THE SURGEON CANNOT ATTRIBUTE THE PATIENT¿S DEATH TO A PARTICULAR DEVICE USED IN THE CASE (4 USED), BUT CANNOT RULE OUT ANY OF THE DEVICES EITHER. WAS THE PATIENT GIVEN ANY PRE-OP ANTICOAGULANTS OR HAD THEY BEEN ON CHRONIC ANTICOAGULANT THERAPY PRIOR TO THE SURGERY; IF SO, WHICH: SHE WAS TAKING NO ANTICOAGULANT STYLE MEDICATION OTHER THAN HEPARIN SUBCUTANEOUSLY, AS IS STANDARD PRE-OP PROTOCOL. POST OP ¿ PATIENT WAS TAKEN TO INTENSIVE CARE FOR MONITORING BECAUSE OF THE BLEEDING DURING THE SURGERY. THE HEMOSTASIS LOOKED PERFECT AT THE END OF THE SURGERY. THURSDAY ¿ THERE WAS NOTHING UNUSUAL WAS MONITORED. FRIDAY - DRAIN EXSUDANT WAS ACCEPTABLE FOR THIS TYPE OF SURGERY A HEMOBLOGIN CONTROL TEST WAS DONE ONCE AND WAS IN THE NORMAL LIMITS FOR THIS TYPE OF SURGERY SATURDAY - MORE SIGNIFICANT DRAINAGE. A HEMOGLOBIN CONTROL TEST WAS DONE AT 6H PERIODS, WITHIN ACCEPTABLE LIMITS EACH TIME 3AM PATIENT CALLED FOR ASSISTANCE, ALMOST IMMEDIATELY FELL INTO SHOCK, REQUIRE EMERGENCY REOPERATION. LAPARATOMY SPLENECTOMY. MASSIVE HEMOPERITONEUM, AT LEAST 3L OF BLOOD WAS RECOVERED. SOURCE OF BLEEDING NOT OBJECTIFIED AT THIS POINT. SPLEEN WAS NORMAL, NO VISIBLE SIGNS OF HEMATOMA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEATH COMPLAINT WAS PREVIOUSLY SUBMITTED ON 3005075853-2016-01433.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISTAL PANCREATECTOMY PROCEDURE, THERE WAS A PROBLEM WITH TWO DEVICES. DEVICE #1 HAD MULTIPLE ERROR CODES, SUCH AS REPLACE INSTRUMENT, ETC. THEY UNPLUGGED AND REPLUGGED IN THE DEVICE. THERE WERE TONES ON GENERATOR, USED IT A BIT AND THEN THERE WAS NOTHING. THIS HAPPENED 2-3 TIMES. THE SURGEON WAS TAKING SMALL BITES OF TISSUE AND THERE WERE NO CLIPS PRESENT WHERE HE WAS WORKING. DEVICE WAS THEN USED EITHER ON THE SPLENIC VEIN OR A BRANCH OF THE SPLENIC VEIN, THE SURGEON COULD NOT SAY FOR SURE. THE DEVICE WAS ACTIVATED AND THE TWO TONES WERE HEARD. THERE WAS BLEEDING. HE TRIED TO CONTROL THE BLEEDING WITH THIS DEVICE, BUT COULD NOT. THEN TRIED TO CONTROL THE BLEEDING WITH CLIPS, BUT AGAIN WAS NOT ABLE TO DO SO. OPENED A COMPETITOR STAPLING DEVICE AND APPLIED A LINE OF STAPLES, THIS SEEM TO STOP THE BLEEDING. THE SITE WAS CLEANED TO CONFIRM HEMOSTASIS. THE SURGEON ASKED THE STAFF TO KEEP THE DEVICE, BUT IT WAS INADVERTENTLY DISCARDED. DEVICE #2 - A NEW DEVICE, SAME LOT, WAS OPENED AND USED TO COMPLETE THE CASE. THE PATIENT WAS GIVEN A DRAIN. THIS DEVICE WAS ALSO DISCARDED. DUE TO THE DIFFICULTIES EXPERIENCED DURING THE CASE THE PATIENT WAS SENT TO INTENSIVE CARE FOR ADDITIONAL MONITORING. WHILE IN INTENSIVE CARE, THERE WAS NOTHING COMING FROM THE DRAIN. THE STAFF DID AN UNKNOWN TEST TO CHECK FOR BLEEDING AND THERE WERE NO SIGNS OF BLEEDING. DURING THE NIGHT THE PATIENT WAS NOT DOING WELL, WENT INTO SHOCK AND WAS BROUGHT BACK TO THE OR FOR A REOPERATION. THE SURGEON COULD NOT TELL WHERE THE BLEEDING WAS COMING FROM. THE SPLEEN WAS REMOVED AND HE COULD SEE THE STAPLING LINE AND THE CLIPS BUT WAS UNABLE TO COUNT IF THEY WERE ALL THERE. THE PATIENT DID NOT SURVIVE. THE SURGEON CANNOT ATTRIBUTE THE PATIENT'S DEATH TO A PARTICULAR DEVICE, BUT CANNOT RULE OUT ANY OF THE DEVICES EITHER. ALL DEVICES IN THE CASE WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155848 ENSEAL G2 STRAIGHT JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR