BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE ENDOSTITCH

    MDR report key: 1346780 · Received March 16, 2009

    Report

    Report Number
    1346780
    Event Type
    Malfunction
    Date Received
    March 16, 2009
    Date of Event
    March 13, 2009
    Report Date
    March 16, 2009
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    CERVIX SUTURED - NEEDLE BROKE IN HALF. X-RAY CONFIRMED FRAGMENT LOCATION AND NEEDLE FRAGMENT REMOVED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE ENDOSTITCH SUTURING DEVICE, ENDOSCOPIC MFJ COVIDIEN UNITED STATES SURGICAL CORPORATION 170053 A8K1502

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR