BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK AUTOMATIC ENDO5 APPLIER, MEDIUM-LARGE

    MDR report key: 2093507 · Received April 6, 2011

    Report

    Report Number
    3003898360-2011-00131
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MANUFACTURER, HOWEVER, THE 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 CLIP DID NOT CLOSE PROPERLY AND DID NOT STAY ON THE VESSEL. THE DOCTOR WAS ABLE TO REMOVE THE CLIP FROM THE PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK AUTOMATIC ENDO5 APPLIER, MEDIUM-LARGE ENDO APPLIER FZP TELEFLEX MEDICAL NA 10A1100003

    Patients

    Seq Age Sex Outcome Treatment
    1