BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 30-3.5 SULU

    MDR report key: 2974209 · Received February 12, 2013

    Report

    Report Number
    1219930-2013-00085
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 20, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE STAPLER WAS STUCK ON TISSUE AFTER CLOSING. THE JAWS WERE LOCKED AFTER CLAMPING AND IT WAS CUT OFF FOR REMOVAL. REINFORCEMENT MATERIAL WAS NOT USED WITH THE STAPLING DEVICE. SURGERY TIME WAS EXTENDED BEYOND 30 MINUTES WITH NO EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62246 ENDO GIA ROTICULATOR 30-3.5 SULU DISPOSABLE STAPLER GDW COVIDIEN LP, FORMERLY US SURGICAL N2A0190LX

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Disability