BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3022623 · Received March 27, 2013

    Report

    Report Number
    3005075853-2013-01409
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 5, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. WHEN THE PATIENT WAS OPENED, IT WAS NOTED THAT THE ENTIRE LEFT STAPLE LINE OF THE GASTRIC CONDUIT WAS DEAD. THE REST OF THE STOMACH HAD GOOD BLOOD FLOW. THE SURGEON RESECTED THE ENTIRE LEFT STAPLE LINE. THIS WAS FROM THE ORIGINAL STAPLE LINE PRODUCED BY THE PSE60A WITH GREEN RELOADS. THE ECS29A WAS SECONDARY. THE PATIENT IS CURRENTLY STABLE AND PLANNING TO GO HOME WITH A FEEDING TUBE. THE PATIENT WILL BE HOME FOR A FEW MONTHS AND THEN RETURN FOR THE SURGEON TO PERFORM A COLONIC INTERPOSITION PROCEDURE. THERE IS ALSO A CORRECTION TO WHAT WAS ORIGINALLY REPORTED AS "THE SURGEON IS PLANNING TO GO BACK IN, TO USE SMALL BOWEL ONCE THE TISSUE HEALS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP A MINIMALLY INVASIVE ESOPHAGECTOMY PROCEDURE, SEVEN DAYS POST OP THERE WAS CONCERN FOR A LEAK AND A SWALLOW TEST WAS PERFORMED ON THE PATIENT AND EVERYTHING SEEMED FINE. NINE TO TEN DAYS POST OP THE PATIENT WAS THOUGHT TO HAVE A LEAK, SO THE PATIENT WAS SCOPED AND THERE WAS A HOLE AT THE STAPLE LINE OF THE ESOPHAGUS AND STOMACH ANASTOMOSIS. THE PATIENT WAS DRAINED AND NO OTHER SURGERY WAS PERFORMED AT THAT TIME. THE PLAN WAS TO STENT THE PATIENT A FEW DAYS AFTER THE DRAIN PLACEMENT. THIS MORNING (B)(6) 2103, THE PATIENT WAS CHECKED TO SEE ABOUT PLACING A STENT AND THE TISSUE AROUND THE ENTIRE STAPLE LINE WAS DEAD AND THE WHOLE STAPLE LINE HAD TO BE CUT OUT. THE ESOPHAGUS AND THE STOMACH WERE BOTH CLOSED OFF SEPARATE TO ALLOW THE TISSUE TO HEAL. THE SURGEON IS PLANNING TO GO BACK IN TO USE SMALL BOWEL ONCE THE TISSUE HEALS. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126796 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ECR60G