BEUDAMED
    FDA Adverse Event Death Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3073271 · Received April 23, 2013

    Report

    Report Number
    3005075853-2013-01928
    Event Type
    Death
    Date Received
    April 23, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL SUMMARY FROM THE SALES REPRESENTATIVE: ON (B)(4) APPROXIMATELY AT 10:10AM, I RECEIVED A CALL FROM THE DIRECTOR OF COMMODITY CONTRACTING FOR THE MEMORIAL SYSTEM, SHE STATED THAT DR HAD A PATIENT EXPIRED ON SATURDAY (B)(6) AND THAT HE NO LONGER WANTS TO USE OUR ECHELON. I WAS CURRENTLY AT ANOTHER HOSPITAL AND LEFT IMMEDIATELY. I ARRIVED AT 10:55AM WHERE DR HAD JUST FINISHED A CASE AND HE STEPPED OUT OF THE O.R UNTIL HIS NEXT CASE, WHICH WAS GOING TO START AT 1:45PM. AT THAT POINT I WENT TO THE O.R DIRECTOR AND WE SPOKE IN HER OFFICE ABOUT DR. I TOLD HER THAT DIRECTOR OF CONTRACTING CALLED ME STATING THAT A PATIENT HAD EXPIRED AND HE NO LONGER WANTS TO USE OUR PRODUCT AND DID NOT KNOW ANY MORE DETAILS. SHE IMMEDIATELY TOLD ME NOT TO REPEAT THAT STATEMENT AND THAT THE ONLY ISSUE THAT DR HAD WAS THAT THE DEVICE DID NOT ARTICULATE AS MUCH AS HE NEEDED. THEN SHE SAID "PLEASE TALK TO HIM AND SEE IF HE CAN USE ANY OTHER DEVICE BECAUSE WE WANT TO STAY UNDER CONTRACT." I SAID "I WILL AND I WILL GET BACK TO YOU AS SOON AS I SPEAK WITH HIM." WHEN I LEFT HER OFFICE, I WENT TO MATERIAL MANAGER OFFICE TO ASK HIM IF DR GAVE HIM ANY FEEDBACK ON ANY ISSUES HE IS HAVING WITH THE DEVICE (NOT BRING UP ANY DETAILS OF THE INFORMATION I KNEW). HE STATED THAT DR WANTED AN ENDO CUTTER THAT HAD A LONGER SHAFT LENGTH. I TOLD HIM THAT WE HAVE A SHAFT LENGTH OF 440 AVAILABLE AND I WAS GOING TO OFFER THAT TO DR AS A CHOICE. IT WAS ABOUT 12:50PM, WHEN I REACHED OUT TO MARKETING MANAGER FOR ETHICON ON HIS CELL AND LEFT HIM A MESSAGE TO CALL ME WHEN HE HAD A CHANCE. HE CALLED ME BACK AROUND 1:35PM AND I EXPLAINED MY SITUATION. HE TOLD ME TO GET MORE DETAILED INFORMATION FROM THE SURGEON AND TO CALL HIM BACK. AT 2:05PM DR STARTED HIS CASE AND I ENTERED THE ROOM. IMMEDIATELY THE SURGEON TOLD ME THAT A PATIENT EXPIRED BECAUSE OF A LEAK THIS PAST WEEKEND AND DOES NOT FEEL COMFORTABLE USING THE DEVICE. I ASKED HIM WHAT HAPPEN IN THE LAR CASE, HE STATED THAT THE GUN CUT BUT DID NOT DEPLOY THE STAPLES. WHEN HE OBSERVED THAT NO STAPLES WERE PRESENT, HE HAND SEWED THE COLON. I ASKED HIM IF HE DID THE WATER\AIR TEST AND HE SAID THAT HE DID AND HAD NO LEAKS. MY FOLLOW UP QUESTION WAS IF HE KEPT THE GUN OR RELOAD HE SAID IT WAS NOT HIS JOB TO KNOW THAT INFORMATION. WHEN THE CASE WAS FINISHED I DID A PRESENTATION WITH MY IPAD IN FRONT OF OR4 ON HOW THE DEVICE THREE POINT GAP CONTROL WORKS WITH A VIDEO. I ALSO EXPLAINED TO HIM IF HE USED THE WRONG COLOR RELOAD ON THE TISSUE THE STAPLES COULD HAVE BEEN THERE BUT FROM HIS ANGLE HE DID NOT SEE IT BECAUSE THE LEGS OF THE STAPLES NEVER PENETRATED THROUGH. DR SAID THAT I MIGHT BE RIGHT AND IN THE NEXT CASE HE WILL USE GREEN OR GOLD ON THE SIGMOID. I LEFT DR AND WENT TO MATERIAL MANGER TO ASK ABOUT THE GUN AND THE RELOAD FROM DR LAR CASE HE SAID THAT THEY DID NOT SAVE IT AND THERE WAS NO INCIDENT REPORT MADE. WHILE TALKING TO HIM OR DIRECTOR PASSED BY AND I TOLD HER THAT I HAD SPOKEN WITH DR. AND THAT HE WILL STILL BE USING THE POWERED DEVICE , I ALSO INFORMED HER THAT THE GUN\RELOAD WERE NOT SAVED AND THERE WAS NO INCIDENT REPORT MADE. SHE SAID OKAY AND SHE WALKED AWAY. BEFORE LEAVING THE O.R, I TOLD THE STAFF AND SCHEDULERS TO PLEASE NOTIFY ME IF DR HAS AN LAR OR SIGMOID CASE IN THE FUTURE. WHILE WALKING TO THE ELEVATOR, I CALLED ETHICON MARKETING MANAGER AT 3:45 AND TOLD HIM ALL THE DETAILS I DISCOVERED. AT THAT POINT, HE TOLD ME TO CALL IT IN AND THAT HE HAD ALREADY ADVISED SOME PEOPLE OF THE SITUATION IN A CORPORATE LEVEL. I WALKED TO MY CAR AND CALLED IT IN EVEN THOUGH I DID NOT HAVE THE COMPLETE STORY (DATE OF CASE, ETC). WHEN I FINISHED REPORTING IT, THEY SENT ME AN EMAIL OF THE REPORT. I THEN FORWARD IT TO ETHICON MARKETING MANAGER AT 4:11PM AS HE WAS AWAITING THE PRODUCT INQUIRY. THE FINAL ACT I DID ON MY PART WAS TO CALL DIRECTOR OF COMMODITY CONTRACTING AT 4:30PM AND UPDATE HER ON ALL DETAILS OF WHAT TRANSPIRED. SHE SAID THANK YOU AND IF ANYTHING CAME UP SHE WOULD GIVE ME A CALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE PHYSICIAN HAD FIRED THE DEVICE TWICE USING BLUE RELOADS. ON THE THIRD FIRING ACROSS HERNIA TISSUE IN ARTICULATING MODE THEY OBSERVED THE STAPLE LINE AND DID NOT SEE STAPLES PRESENT; THE CUT LINE WAS LEAKING. THE SURGEON HAND SEWED THE CUT LINE. AT THIS POINT, THE SURGEON CHECKED THE SUTURE LINE FOR LEAKS AND CONTINUED TO COMPLETE THE PROCEDURE. THE SURGEON THEN REPORTED THAT POST OP THE SURGERY ON (B)(6) 2013, THE PATIENT EXPIRED. IT IS NOT KNOWN IF THERE WAS AN AUTOPSY PERFORMED. THERE HAS BEEN NO INCIDENT REPORT FILED AT THE HOSPITAL. NO OTHER INFORMATION WAS PROVIDED FOR THE REP AT THIS TIME. THE DATE OF SURGERY IS UNKNOWN. THE DEVICE WAS DISCARDED THE DAY OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174569 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death RELOAD:ECR60B