BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR* 60-4.8 SULU

    MDR report key: 4275550 · Received November 25, 2014

    Report

    Report Number
    1219930-2014-01096
    Event Type
    Injury
    Date Received
    November 25, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 3, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: THE DEVICE FIRED SOME OF THE STAPLES BUT DID NOT FIRE ALL THE WAY TO THE END. IT IS POSSIBLE THAT FIRING ACROSS ANOTHER STAPLE LINE CONTRIBUTED TO THE PROBLEM. IT WAS ALSO NOTED THAT THERE WERE SOME MALFORMED STAPLES BUT, BECAUSE THERE WERE A FEW STAPLELINES ALREADY FIRED, IT COULD NOT BE CONFIRMED THAT THEY WERE FROM THIS FIRING. TO CORRECT THE PROBLEM, THEY FIRED ANOTHER STAPLER. BECAUSE THE DOCTOR HAD TO MOVE IN FROM THE ORIGINAL STAPLE LINE, THEY LOST ABOUT THE WIDTH OF THE STAPLER IN TISSUE. THE STOMACH SPECIMEN WAS EXAMINED AFTER THE CASE AND STAPLER DID NOT CUT TO END. THERE WAS NO EXTENSION OPERATING TIME, NO BLEEDING AND NO BUTTRESS MATERIAL USED. WE LOOKED AT STOMACH SPECIMEN AFTER CASE AND STAPLER DID NOT CUT TO END. THEY THOUGHT IT DID BUT DID NOT. PRODUCT NUMBER: EGIAUXL. EGIA ULTRA UNIVERSAL XL STAPLER. K083519.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763731 ENDO GIA ROTICULATOR* 60-4.8 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON 030459 H3J0790RS

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability PRODUCT NUMBER: EGIAUXL