BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 45-3.5 SINGLE USE RELOADABLE STAPLER

    MDR report key: 2121444 · Received June 7, 2011

    Report

    Report Number
    2647580-2011-00380
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 26, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOWER ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE STAPLES DID NOT DEPLOY AND TISSUE WAS DAMAGED. THE SURGEON HAD TO THEN STAPLE LOWER DOWN WITH CONTOUR AND CREATED A COLOSTOMY. THE PT'S STATUS IS OK. NO ADD'L INFO AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 45-3.5 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P1A0025

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability