BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 45 ARTICULATING MED/THICK SULU

    MDR report key: 2974174 · Received February 12, 2013

    Report

    Report Number
    1219930-2013-00064
    Event Type
    Injury
    Date Received
    February 12, 2013
    Report Date
    January 14, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE RELOAD WOULD NOT RELEASE OFF THE TISSUE. THE SURGEON CUT AND STAPLED ALONG THE STAPLE RELOAD TO REMOVE IT FROM TISSUE. REINFORCEMENT MATERIAL WAS NOT USED IN CONJUNCTION WITH THE STAPLING DEVICE. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62015 EGIA 45 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N1L0505ULX

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability