BEUDAMED
    FDA Adverse Event Injury Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2080386 · Received May 6, 2011

    Report

    Report Number
    3005075853-2011-01846
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 18, 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 ANTRO GASTRIC TUMOR. PROCEDURE: SUBTOTAL GASTRECTOMY + LIVER BIOXEA. THE PATIENT WAS HYPERTENSIVE, THE CANCER HAD MAKE METASTASIS. STAPLE LINE OPENED (B)(6) IN THE DUODENAL MUNON.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE ARE NOT ANY SPECIMENS FOR RETURN THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFORMATION, THE MANUFACTURING RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MANUFACTURING OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT.

    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 G4U07Y

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R CARTRIDGE