BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK AUTO ENDO5 APPLIER ML

    MDR report key: 1880900 · Received October 5, 2010

    Report

    Report Number
    3003898360-2010-00431
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 15, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE APPLIER FAILED TO DEPLOY CLIPS DURING A PROCEDURE. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK AUTO ENDO5 APPLIER ML ENDO APPLIER FZP TELEFLEX MEDICAL NA 01F1000383

    Patients

    Seq Age Sex Outcome Treatment
    1