BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 3770609 · Received February 3, 2014

    Report

    Report Number
    2647580-2014-00074
    Event Type
    Injury
    Date Received
    February 3, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 15, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE DEVICE WAS FIRED AS USUAL. THERE WAS LITTLE DIFFICULTY IN THE TURNING THE WING NUT, BUT IT COULD BE TURNED AND THE DEVICE WAS RETRIEVED. THE ANVIL DIDN'T COME OUT, ONLY THE SHAFT WAS RETRIEVED. THE RING ON THE ANAL SIDE WAS CONFIRMED. THE STAPLES DIDN'T FORM PROPERLY. THE ORAL SIDE WAS NOT CUT COMPLETELY. THE ANVIL LEFT IN ORAL SIDE WAS TITLED. THE ANVIL WAS RESECTED FROM THE TISSUE WITH SCISSORS. AN EEA28 WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71498 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN P3H10134X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention