BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HORIZON CLIP APPLIER

    MDR report key: 1933870 · Received December 7, 2010

    Report

    Report Number
    1044475-2010-00168
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 16, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATES THAT THEY ARE AWARE THAT THE IFU (INFORMATION FOR USE) INDICATES AN INSPECTION OF JAW ALIGNMENT PRIOR TO USE. MFG FACILITY AWARE OF REPORTED ISSUE. NO CATALOG NUMBER, NO LOT NUMBER, AND NO SAMPLE AVAILABLE FOR EVAL. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: AN ISSUE WAS REPORTED REGARDING HORIZON CLIP APPLIER. IT WAS REPORTED THAT THE TIPS WERE NOT FLUSH WITH EACH OTHER WHEN CLOSED, CAUSING THE CLIP TO CUT THE VESSEL THAT THE DOCTOR WAS TRYING TO CLIP. ADDITIONAL INFO REGARDING THE EVENT WAS REQUESTED. THE ADDITIONAL INFO RECEIVED STATED THAT THE SURGEON USED SUTURES TO CLOSE THE VESSEL. IT WAS ALSO STATED THAT THE APPLIER HAD A YELLOW HANDLE. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HORIZON CLIP APPLIER CLIP APPLIER FZP TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention