BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    MDR report key: 4041016 · Received August 6, 2014

    Report

    Report Number
    1219930-2014-00607
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 14, 2012
    Report Date
    June 20, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY US SURGICAL
    Product Code
    FZP
    PMA / PMN Number
    K061288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORTER: THE DEVICE WAS BROKEN OUT OF THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459118 ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP DISPOSABLE CLIP APPLIER FZP COVIDIEN LP, FORMERLY US SURGICAL N2C0294X

    Patients

    Seq Age Sex Outcome Treatment
    1