BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA MEDIUM/THICK RADIAL RELOAD

    MDR report key: 3170185 · Received June 7, 2013

    Report

    Report Number
    1219930-2013-00440
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 22, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GDW
    PMA / PMN Number
    K102291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE ORIGINAL HANDLE AND LOAD WERE USED AND EVERYTHING WENT WELL. UPON RELOADING, USING THE SAME HANDLE, THE DEVICE CUT BUT DID NOT STAPLE. THE SURGEON TRIED USING A NEW DEVICE TO STOP THE LEAKS. THE SURGEON THEN HAD TO MANUALLY SUTURE THE AREA WHERE IT DID NOT STAPLE. THE CASE WAS DELAYED BY SEVERAL HOURS DUE TO LEAKS THAT KEPT OCCURRING. A 650CC OF BLOOD LOSS OCCURRED. PATIENT WAS TRANSFUSED. NO OTHER MANUFACTURER PRODUCT WAS USED, NO REINFORCEMENT MATERIAL USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253987 ENDO GIA MEDIUM/THICK RADIAL RELOAD DISPOSABLE STAPLER GDW COVIDIEN, FORMERLY US SUR N2H0657UX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention