BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 3001364 · Received March 6, 2013

    Report

    Report Number
    1219930-2013-00171
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 26, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER. EEA 28 MISFIRED DURING AN LAR AND ANASTOMOSIS WAS INCOMPLETE AND OPEN AND HAD TO BE HAND SEWN. ANASTOMOSIS WAS REPAIRED BY HAND AND THE PT WAS GIVEN A LOOP ILEOSTOMY. REINFORCEMENT MATERIAL WAS NOT USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96059 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL U8E34H

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other