BEUDAMED
    FDA Adverse Event Injury Summary report: N

    29 MM ENDOCIRCULAR STAPLER

    MDR report key: 1614832 · Received February 19, 2010

    Report

    Report Number
    MW5014874
    Event Type
    Injury
    Date Received
    February 19, 2010
    Date of Event
    February 10, 2001
    Report Date
    February 19, 2010
    Manufacturer
    J & J
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLER LOCKED WHILE DR WAS APPROXIMATING BOWEL FOR ANASTOMOSIS. DID NOT MAKE A COMPLETE "DOUGHNUT" DURING ANASTOMOSIS. DID NOT PASS LEAK TEST. DR HAD TO TAKE ADDITIONAL BOWEL AND PERFORM ANASTOMOSIS WITH ANOTHER STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 29 MM ENDOCIRCULAR STAPLER STAPLER GDW J & J F4R400

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Disability