BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA MEDIUM/THICK RADIAL RELOAD

    MDR report key: 2911108 · Received January 7, 2013

    Report

    Report Number
    1219930-2013-00008
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 11, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K102291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE PRODUCTS WERE DISPOSED BECAUSE NO INTRA-OPERATIVE ISSUES OCCURRED. POST-OP, AN ANASTOMOTIC LEAK FOLLOWED THE PROCEDURE. THE PATIENT CAME BACK AND RECEIVED A LAPAROTOMY AND DIVERTING ILEOSTOMY. REINFORCEMENT MATERIAL WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8140 ENDO GIA MEDIUM/THICK RADIAL RELOAD DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R