BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP 5MM CLIP APPLIER

    MDR report key: 3810345 · Received April 10, 2014

    Report

    Report Number
    1219930-2014-00296
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Report Date
    March 25, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    FZP
    PMA / PMN Number
    K954435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT THE DEVICE COULD DELIVER ONLY 4 CLIPS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216532 ENDO CLIP 5MM CLIP APPLIER DISPOSABLE CLIP APPLIER FZP COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N3J1456X

    Patients

    Seq Age Sex Outcome Treatment
    1