BEUDAMED
    FDA Adverse Event Summary report: N

    ECHELON FLEX 45 ENDOPATH

    MDR report key: 2082634 · Received May 2, 2011

    Report

    Report Number
    2082634
    Date Received
    May 2, 2011
    Date of Event
    April 10, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING A LAPAROSCOPIC SIGMOID COLON RESECTION WITH TAKEDOWN OF COLOVESICAL FISTULA AND DIVERTING LOOP ILEOSTOMY. THE COLOVESICAL FISTULA WAS COMPLETELY TAKEN DOWN. THE DISTAL TRANSECTION MARK WAS COMPLETELY SKELETONIZED. ONCE THIS WAS DONE, THE AREA WAS ATTEMPTED TO BE TRANSECTED WITH AN ENDO GIA STAPLER. UNFORTUNATELY THE STAPLER DID NOT CLOSE AND WOULD NOT FIRE. AFTER THIS, IT WAS DECIDED TO USE A 60 MM ECHELON STAPLER, BUT AGAIN THE STAPLER WAS CLOSED AND IT DID NOT FIRE. UNFORTUNATELY, THE STAPLER GOT STUCK IN THE ON POSITION AND IT WOULD NOT OPEN. BECAUSE OF THIS, THE INCISION WAS JUST EXTENDED SLIGHTLY DISTALLY. USING A 60 MM LINEAR STAPLER WAS PLACED DISTAL TO THE ECHELON STAPLER AND THEN THE BOWEL WAS TRANSECTED USING A SCALPEL. OF NOTE, BEFORE THIS WAS TRANSECTED, THE PROXIMAL BOWEL WAS TRANSECTED USING A GIA STAPLER. AFTER THIS WAS COMPLETE, THE SPECIMEN WAS TAKEN OFF THE FIELD. ECHELON STAPLER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON FLEX 45 ENDOPATH STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, LLC EC45A H4378G
    2 ECHELON FLEX 45 ENDOPATH STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, LLC EC45A H4378G

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR