BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEMOLOK ENDO APPLIER 10MM

    MDR report key: 1950186 · Received December 10, 2010

    Report

    Report Number
    1044475-2010-00151
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 16, 2010
    Report Date
    November 8, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE DEVICE HAS NOT BEEN RECEIVED. INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING A SURGERY, THE OPERATOR LOADED THE CLIPS INTO APPLIER THEN INSERTED THEM INTO THE BODY THROUGH THE TROCAR. THE CLIP COULD NOT BE CLOSED ON THE ARTERY. OTHER CLIPS WERE USED SUCCESSFULLY. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEMOLOK ENDO APPLIER 10MM CLIP APPLIER FZP TELEFLEX MEDICAL NA 938069-011

    Patients

    Seq Age Sex Outcome Treatment
    1