BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 CURVED TIP ARTICULATING

    MDR report key: 2831032 · Received November 2, 2012

    Report

    Report Number
    1219930-2012-00885
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GDW
    PMA / PMN Number
    K101444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: TOTAL MESORECTAL EXCISION (TME). ACCORDING TO THE REPORTER: THE STAPLE LINE DID NOT HOLD TISSUE. THERE WAS ADDITIONAL RELOADS USED BUT SUFFICIENT TISSUE WAS LEFT TO DO AN END TO END ANASTOMOSIS. IT WAS CORRECTED BY FIRING ANOTHER RELOAD DISTALLY TO THE INITIAL STAPLE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA 60 CURVED TIP ARTICULATING DISPOSABLE STAPLER GDW COVIDIEN, FORMERLY US SUR N2D0559ULX

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability