BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA UNIVERSAL

    MDR report key: 3021326 · Received March 20, 2013

    Report

    Report Number
    3021326
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 20, 2013
    Manufacturer
    COVIDIEN ,FORMERLY VALLEY LAB, A DIVISION OF TYCO HEALTH CARE
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    AFTER RELOADING ENDOSCOPIC STAPLER, HANDLE OF STAPLER JAMMED. NO HARM WAS DONE TO THE PATIENT SINCE IT WAS NOT INSIDE. REPLACED WITH NEW ENDOSCOPIC STAPLER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RIGHT-SIDED THORACOSCOPY, PHLEBECTOMY X3 AND MECHANICAL PLEURODESIS AND TALC PLEURODESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115585 ENDO GIA ULTRA UNIVERSAL STAPLER GDW COVIDIEN ,FORMERLY VALLEY LAB, A DIVISION OF TYCO HEALTH CARE * N2K0270UMX

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR NO OTHER THERAPIES