BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEMOLOK ENDO TAKE A PART APPLIER 10MM

    MDR report key: 1935411 · Received November 15, 2010

    Report

    Report Number
    1044475-2010-00163
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 14, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE DEVICE HAS BEEN REC'D, BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: WHEN APPLYING A CLIP AROUND A VESSEL, THE CLIP DOES NOT CLOSE AT THE ADJACENT SIDE TO THE HINGE. THE APPLIER ALSO DROPS CLIPS. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEMOLOK ENDO TAKE A PART APPLIER 10MM CLIP APPLIER FZP TELEFLEX MEDICAL NA 0944263

    Patients

    Seq Age Sex Outcome Treatment
    1