BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA MEDIUM/THICK RADIAL RELOAD

    MDR report key: 4130253 · Received September 30, 2014

    Report

    Report Number
    1219930-2014-00900
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K102291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE RELOAD SHOT ONLY THE HALF AND THEN, THE ENDO GIA BROKE, AND THEN WAS LOCKED. A TA6048S WAS USED TO DO THE ANASTOMOSIS MORE CAUDAL TO THE CUT PERFORMED WITH FOR THE RADIAL ENDO GIA. THE ENDO GIA STAPLE LINE WAS REMOVED. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607722 ENDO GIA MEDIUM/THICK RADIAL RELOAD DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIARADMT N3M0579UX

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability