BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ILS 29MM, CURVED

    MDR report key: 1911195 · Received November 30, 2010

    Report

    Report Number
    3005075853-2010-06761
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 9, 2009
    Report Date
    November 10, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION REQUESTED: ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010: "THE REGISTRAR FIRED THE SAME ECS AGAIN AFTER IT FAILED TO FIRE THE FIRST TIME. I HAVE NO IDEA IF THE SURGEON AND ASSISTANT HAD BEEN TRAINED AS THE HOSPITAL IS NOT ONE IN WHICH I WORK, I WAS MERELY THERE WITH DELEGATES ON A PROF ED COURSE WATCHING THE OPERATION VIA LIVE LINK. I ASSUME IT WAS FIRED A SECOND TIME AS IT APPEARED AS IF NONE OF THE MECHANISMS HAD WORKED ON FIRST FIRING, I.E THE TISSUE HAD NOT BEEN TRANSACTED OR CUT AT ALL AND THEREFORE IT APPEARED AS IF THE BLADE HAD NOT ADVANCED. ALSO, NO STAPLES HAD FORMED SO IT APPEARED AS IF THE STAPLES HAD NOT ADVANCED EITHER. I HAD NOT EXPLAINED THE INSTRUMENT COULD ONLY BE FIRED ONCE AS I WAS NOT INVOLVED IN THEIR TRAINING NOR WAS I IN THEATRE WITH THEM; HOWEVER, I ASSUME THAT THEY ARE FULLY AWARE OF THAT BASED ON THEIR TM (B)(6) INSTRUCTION. I DON'T KNOW HOW LONG THE SURGEON AND ASSISTANT HAVE BEEN USING THE INSTRUMENT. I CAN ONLY CONFIRM THAT THERE WERE NO OBVIOUS ADVERSE INCIDENTS AT FIRST, I LEFT (B)(4) ONLY MOMENTS AFTER THE OCCURRENCE AND HAVE NOT RETURNED SINCE." BELOW IS A FULL DESCRIPTION OF WHAT OCCURRED AS RELAYED TO ANOTHER SALES REP: "EXPLAINED BELOW IN AS MOST DETAIL AS I CAN OFFER IS MY UNDERSTANDING OF WHAT HAPPENED TODAY: THE SURGEON WAS USING THE NEW CDH29 STAPLER. THE CASE WAS INITIALLY LISTED AS AN LAR; HOWEVER, THE TUMOUR WAS LOCATED IN THE SIGMOID COLON WITH LESS ADHESIONS THAN EXPECTED SO ENDED UP BEING A HIGH ANTERIOR RESECTION. AN ASSISTANT WHO WAS UNSCRUBBED FIRED THE STAPLER. THE INITIAL TRANSECTION OF THE BOWEL WAS MADE USING AN ATS45 AND A BLUE RELOAD. IT PROVED TO BE PROBLEMATIC AS WHEN THE CIRCULAR STAPLER WAS INSERTED AND PRESSED AGAINST THE STAPLE LINE IT CAUSED THE STAPLE LINE TO LEAK FAECES. THE CDH WAS PLACED SO AS TO ENSURE REMOVAL OF THE PROBLEMATIC PART OF THE STAPLE LINE WITH THE DONUTS. THE ANVIL WAS CONNECTED TO THE DEVICE CORRECTLY, THERE WAS NO TISSUE BUNCHING AND THE DESCENDING COLON WAS CHECKED 3 TIMES TO ENSURE IT WAS NOT TWISTED. THE ASSISTANT WOUND DOWN THE GUN UNDER THE INSTRUCTION OF THE CONSULTANT WHO ADVISED THAT HE LIKES THE BAR TO BE NEAR THE BOTTOM OF THE GREEN TISSUE COMPRESSION SCALE. SOME DELEGATES WERE JUST LEAVING THE LECTURE ROOM AS THE CDH WAS FIRED AND THEREFORE MY ATTENTIONS WERE A BIT DISTRACTED AS I WAS SAYING GOODBYE TO THEM. HOWEVER, AS FAR AS I UNDERSTAND, ON OPENING THE GUN A LITTLE TO FACILITATE REMOVAL, IT APPEARS THAT THE GUN HAD NOT FIRED, THAT NO ANASTOMOSIS WAS FORMED AND NO CUT WAS MADE. THE GUN WAS THEN CLOSED DOWN AGAIN AS THE CONSULTANT DID NOT WANT THE FAECES THAT HAD PREVIOUSLY BEEN OBSTRUCTED IN THE BOWEL DUE TO THE TUMOUR TO LEAK OUT INTO THE ABDOMINAL CAVITY. THE GUN WAS THEN CLOSED DOWN AND FIRED 'PROPERLY' UNDER INSTRUCTION FROM THE CONSULTANT. THIS TIME ON OPENING TO REMOVE, IT APPEARED THAT THE ANASTOMOSIS HAD NOT FORMED ANTERIORLY. A COUPLE OF SUTURES WERE PLACED TO HOLD THE ANTERIOR TRANSECTED TISSUE TOGETHER AND THE SURGEON THEN PROCEEDED TO DISSECT FURTHER DOWN THE RECTUM IN ORDER TO FACILITATE A FURTHER TRANSECTION. THIS TIME AN ECHELON FLEX 60 WITH GOLD RELOAD WAS USED TO TRANSECT THE RECTUM AND THE GUN FIRED WELL WITH NO STAPLE LINE LEAKAGE. THE LIVE FEED WAS TURNED OFF AT THIS POINT AS DELEGATES WERE ALL LEAVING SO I CANNOT CONFIRM WHAT GUN WAS USED TO COMPLETE THE SECOND ANASTOMOSIS. I SPOKE WITH PROF (B)(6) AND EXPLAINED THAT EITHER INCOMPLETE FIRING OF THE CDH WITH NO AUDIBLE CRUNCH CAN BE RESPONSIBLE FOR MISFIRE. ALTERNATIVELY, IF THE HANDLE WAS PARTIALLY SQUEEZED, THEREBY INITIATING STAPLE FORMATION AND BLADE ADVANCEMENT, BUT THEN LET GO, THE STAPLES WOULD NOT HAVE FORMED PROPERLY BUT THE BLADE WOULD HAVE CUT THROUGH THE TISSUE ANYWAY. I ALSO ASSURED HIM THAT THE MECHANICS OF THE NEW STAPLER ARE IDENTICAL TO THE OLD ONE AND THEREFORE THE SAME FIRING SEQUENCE MUST BE FOLLOWED. I OFFERED TO GO INTO THEATRE BEFORE THE SECOND GUN WAS FIRED TO TALK THE STAFF THROUGH THE PRODUCT AND ALSO OFFERED TO STAY AFTER THE CASE TO DISCUSS FURTHER, HOWEVER, THE OFFER WAS DECLINED. THE PATIENT, BASED ON WHAT I SAW OF THE SECOND ANASTOMOSIS ATTEMPT, SHOULD SUFFER NO ADVERSE CONSEQUENCES AS A RESULT OF THE MISFIRE. PROF (B)(6) WAS QUITE CALM AND UNDETERRED SAYING THAT MECHANICAL FAILURE IS UNFORTUNATELY INEVITABLE SOMETIMES. HE ALSO ADVISED HE WOULD SEND BACK THE MISFIRED GUN AS PER OUR NORMAL PRODUCT RETURNS PROCEDURE. I HOPE THAT THIS HELPS EXPLAIN EXACTLY WHAT HAPPENED. I WOULD GUESS THAT THE ASSISTANT FIRING THE GUN HESITATED AND LET GO OF THE HANDLE BEFORE THE FIRING SEQUENCE WAS COMPLETE AND THEN RE-PRESSED IT CAUSING 'DOUBLE CUTTING' OF THE TISSUE. BUT, OBVIOUSLY, I CANNOT SAY FOR SURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIGH ANTERIOR RESECTION PROCEDURE (AS INITIALLY REPORTED BY THE TM), THE INITIAL TRANSECTION OF THE BOWEL WAS MADE USING AN ATS45 AND A BLUE RELOAD. IT PROVED TO BE PROBLEMATIC AS WHEN THE CIRCULAR STAPLER WAS INSERTED AND PRESSED AGAINST THE STAPLE LINE IT CAUSED THE STAPLE LINE TO LEAK FECES. THE ECS WAS PLACED BY A REGISTRAR AND POSITIONED SO AS TO ENSURE REMOVAL OF THE PROBLEMATIC PART OF THE STAPLE LINE WITH THE DONUTS. THE ANVIL WAS CONNECTED TO THE DEVICE CORRECTLY, THERE WAS NO TISSUE BUNCHING AND THE DESCENDING COLON WAS CHECKED THREE TIMES TO ENSURE IT WAS NOT TWISTED. THE REGISTRAR CLOSED THE ECS GUN UNDER THE INSTRUCTION OF THE SURGEON WHO ADVISED THAT HE LIKED THE BAR TO BE NEAR THE BOTTOM OF THE GREEN TISSUE COMPRESSION SCALE. ON OPENING THE GUN A LITTLE TO FACILITATE REMOVAL, IT APPEARS THAT THE GUN HAD NOT FIRED, THAT NO ANASTOMOSIS WAS FORMED AND NO CUT WAS MADE. THE GUN WAS THEN CLOSED DOWN AGAIN AS THE CONSULTANT DID NOT WANT THE FECES THAT HAD PREVIOUSLY BEEN OBSTRUCTED IN THE BOWEL TO LEAK OUT. THE GUN WAS THEN CLOSED DOWN AND FIRED UNDER INSTRUCTION FROM THE CONSULTANT. THIS TIME ON OPENING TO REMOVE, IT APPEARED THAT THE ANASTOMOSIS HAD NOT FORMED ANTERIORLY. A COUPLE OF SUTURES WERE PLACED TO HOLD THE ANTERIOR TRANSECTED TISSUE TOGETHER AND THE SURGEON THEN PROCEEDED TO DISSECT FURTHER DOWN THE RECTUM IN ORDER TO FACILITATE A FURTHER TRANSECTION. THIS TIME AN ECHELON FLEX 60 WITH GOLD RELOAD WAS USED TO TRANSECT THE RECTUM. THE TM CANNOT CONFIRM WHAT GUN WAS USED TO COMPLETE THE SECOND ANASTOMOSIS. BASED ON WHAT THE TM SAW OF THE SECOND ANASTOMOSIS ATTEMPT, THE PATIENT SHOULD SUFFER NO ADVERSE CONSEQUENCES AS A RESULT OF THE MISFIRE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1