BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 2602918 · Received June 7, 2012

    Report

    Report Number
    3005075853-2012-02727
    Event Type
    Death
    Date Received
    June 7, 2012
    Date of Event
    May 2, 2012
    Report Date
    May 3, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANVIL AND WASHER WERE DISCARDED AND NOT AVAILABLE FOR EVALUATION AN ONSITE ANALYSIS WAS CONDUCTED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS NOTED TO BE IN GOOD VISUAL CONDITION. THE ANVIL AND WASHER WERE DISPOSED AFTER THE SURGICAL PROCEDURE. THEREFORE THE CONDITION OF THE ANVIL OR WASHER IS UNKNOWN. THE HOSPITAL DID NOT ALLOW COMPLETE FUNCTIONAL TESTING OF THE DEVICES, THEREFORE ONLY A DRY FIRE WAS PERFORMED TO ASSESS THE MOVEMENT OF THE FIRING MECHANISM AND CONDITION OF THE KNIFE AND DRIVERS. THE DRY FIRE REVEALED THAT THE FIRING MECHANISM WAS MOVING APPROPRIATELY WITHOUT ANY DIFFICULTIES. THE DEVICE WAS DIALED DOWN UNTIL THE INDICATOR REACHED THE LOW B SETTING BY ROTATING THE ADJUSTING KNOB. THE CLOSING MECHANISM WAS NOTED TO WORK AS INTENDED. NO FURTHER TESTING WAS PERFORMED. PER THE EVENT DESCRIPTION AND ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON THE COMPLAINT COULD NOT BE CONFIRMED AS THE DEVICE CLOSING MECHANISM WAS NOTED TO WORK PROPERLY. IN ADDITION, AS THE ANVIL AND WASHER WERE DISCARDED AFTER THE SURGICAL PROCEDURE, INFORMATION AS TO WHY THERE WAS NO CRUNCH COULD NOT BE ASSESSED. FURTHERMORE AS THE DEVICE WAS NOT TEST FIRE, THE DEVICE'S ABILITY TO CUT AND PROPERLY FORM STAPLES, AND REMOVAL OF THE DEVICE COULD NOT BE ASSESSED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE. THE DEVICE RETAINED BY RISK MANAGEMENT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS. THE SURGEON REPORTED THAT HE STEP AWAY FROM THE ABDOMEN AND EVENTUALLY REMOVED THE DEVICE. THE DONUTS WERE GOOD. HOWEVER, THE TISSUE APPEARED TO BE "WIDEN", WHICH WAS OBSERVED VIA A SCOPE. THE SURGEON TOOK DOWN THE ANASTOMOSIS AND IT WAS REDONE USING ANOTHER DEVICE. THE DEVICE FIRED FINE BUT LEFT A RECTOVAGINAL FISTULA. AS THE SURGERY WAS ALREADY INTO THREE HOURS, INCLUDING REPAIR OF THE FISTULA, THE SURGEON ELECTED NOT TO REANASTOMOSE. THE PROXIMAL COLON WAS STAPLED. POST OPERATIVELY, THE PATIENT DEVELOPED A COLD RIGHT FOOT AND THE PULSE COULD NOT BE PALPATED. THE PATIENT WAS HEPARINIZED. TWO TO THREE HOURS LATER, THE ENTIRE RIGHT LEG WAS COLD. THE PATIENT HAD DEVELOPED A RIGHT POPLITEAL FOSSA DVT. THE SURGEON STATES THAT HE CONTACTED A VASCULAR SURGEON AND THE PATIENT WAS TRANSPORT TO (B)(6). DURING THE TRANSPORT, THE PATIENT CODED AT THE AIRPORT BUT WAS REVIVED. ONCE THE PATIENT REACHED THE FACILITY, THE VASCULAR SURGEON WANTED TO AMPUTATE THE RIGHT LEG, BUT THE INDICATED THE PATIENT WAS TOO ILL. THE VASCULAR SURGEON INDICATED THAT THERE WAS SOMETHING GOING ON WITH THE ABDOMEN. AS THE PATIENT WAS TOO ILL TO UNDERGO ANOTHER PROCEDURE, THE BELLY WAS OPENED AT THE BEDSIDE. A 1 X2 HOLE WAS OBSERVED WITH ENTERIC CONTENT IN THE ABDOMEN. THE OMENTUM AND THE SMALL BOWEL WERE INFARCTED. THE SURGEON REPORTED THAT THE PATIENT DEVELOPED CATASTROPHIC ANTIPHOSPHOLIPID ANTIBODY SYNDROME AND EXPIRED WITHIN 24 HOURS AFTER BEING TRANSPORTED TO (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT ON (B)(6), 2012 A SIGMOID RESECTION WAS ATTEMPTED WITH THE PLAN TO LEAVE THE COLOSTOMY TO ALLOW THE BOWEL TO HEAL. THE SURGEON STATED THAT THE TRANSVERSE COLON WAS MOBILIZED. THERE WERE SEVERAL ADHESIONS THAT HAD TO BE REMOVED TO FREE THE SMALL BOWEL TO FIND THE RECTAL STUMP. THE DISTAL END OF THE BOWEL WAS STAPLED AND THE PROXIMAL END WAS SUTURED. THE DEVICE WAS PLACED TRANSANALLY BY THE SCRUB TECH. THE TROCAR WAS BROUGHT OUT ANTERIOR TO THE SUTURE LINE. THE SURGEON STATED THAT HE PLACED TWO FINGERS IN THE VAGINA AND ONE FINGER IN THE RECTUM TO ENSURE THAT THE VAGINA WAS NOT STAPLED. THE SCRUB TECH TURNED THE ADJUSTING KNOB TO CLOSE THE DEVICE, WHICH WAS DIFFICULT INITIALLY. THE SURGEON STATED THAT HE THOUGHT THIS WAS DUE TO THE RADIATED TISSUE AND THE FIBROSIS FROM RADIATION. WHEN THE DEVICE WAS IN THE GREEN ZONE, IT SEEMED TO WORK AS NORMAL. THE SAFETY WAS REMOVED AND THE DEVICE WAS FIRED BY THE SCRUB TECH. THE SURGEON STATED THAT THE CRUNCH SOUND WAS NOT HEARD. THE SCRUB TECH ATTEMPTED TO REMOVE THE DEVICE WITH DIFFICULTY. IT IS BELIEVED THAT THE DEVICE WAS TURNED 1 ½ TURNS TO OPEN. HOWEVER, THE SURGEON WAS NOT CERTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH CIR STAPLER ENDOSCOPE AND/OR ACCESSORIES KOG ETHICON ENDO-SURGERY, LLC. UNK E4LY53

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death