BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 60-3.5 SINGLE USE RELOADABLE STAPLER

    MDR report key: 2132225 · Received June 14, 2011

    Report

    Report Number
    2647580-2011-00391
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 17, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: BOWEL RESECTION. ACCORDING TO THE REPORTER: THE DEVICE CLAMPED DOWN ON BOWEL BUT DID NOT FIRE STAPLES, SO BOWEL WAS CUT. THE DEVICE OPENED TO FIND BOWEL OPEN. BOWEL CONTENTS WERE SPILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 60-3.5 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P1B0288

    Patients

    Seq Age Sex Outcome Treatment
    1 Other