BEUDAMED
    FDA Adverse Event Death Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2080401 · Received May 6, 2011

    Report

    Report Number
    3005075853-2011-01847
    Event Type
    Death
    Date Received
    May 6, 2011
    Date of Event
    February 3, 2011
    Report Date
    April 15, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010: (B)(6), DIAGNOSTIC: BIG TUMOR SPLENIC FLEXURE COLON. PROCEDURE: HEMICOLECTOMY AND RESECTION SMALL INTESTINE. THE PATIENT WAS OBESE AND HAS PULMONARY EMPHYSEMA. PATIENT EXPIRED, DEAD CAUSE MULTIPLE ORGANIC DIFFUSION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: ASKED IF A PATHOLOGY SPECIMEN WAS AVAILABLE FOR RETURN. RESPONSE: THERE ARE NOT ANY SPECIMENS FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: EES MD REVIEWED AN INTRAOPERATIVE PHOTO THAT APPEARS TO BE A PARTIALLY OPENED ANASTOMOSIS BETWEEN THE SMALL BOWEL AND SOME OTHER STRUCTURE, PRESUMABLY COLON. IT SHOWS AN APPROXIMATE 3 - 4 CM LINEAR OPENING WHERE THE MUCOSA OF THE BOWEL IS READILY IDENTIFIABLE. IT DOES APPEAR THAT THE ANASTOMOTIC BREAKDOWN IS RELATIVELY FRESH BUT THERE ARE NO STAPLES SEEN IN THIS IMAGE. THERE ARE SOME AREAS ALONG THE OPENED EDGES WHICH TO MY MIND APPEAR TO HAVE THE CRUSHED CONFIGURATION THAT WOULD BE TYPICAL WITH A LINEAR STAPLER CUTTER. IT IS IMPOSSIBLE TO TELL WHAT MAY HAVE CAUSED THIS ANASTOMOTIC DISRUPTION THOUGH ONE WOULD PRESUME THAT THIS STAPLE LINE APPEARED GROSSLY INTACT AT THE TIME OF THE INITIAL OPERATION WHICH LEADS ME TO BELIEVE FAILURE WAS DUE TO TISSUE OR TENSION RELATED ISSUES RATHER THAN STAPLE RELATED ISSUES. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. 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 GASTRIC PROCEDURE, THE COMPLICATIONS PRESENTED WITH THE PRODUCT ARE FILTRATION OF THE STAPLE LINE; IN ONE CASE THE STAPLE LINE OPENED COMPLETELY. DURING THE SURGERY, THE PRODUCTS WORKS VERY GOOD; THE STAPLE LINE FORM PERFECTLY WITH GOOD HEMOSTASIS; THE PROBLEM OCCURS FOUR OR FIVE DAYS LATER CAUSING A REOPERATION OF THE PATIENT. ADDITIONAL INFORMATION BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4U481

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| O| R CARTRIDGE