BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEMOLOK TAKEAPART XL 10MM ENDO APPLIER

    MDR report key: 2900848 · Received December 12, 2012

    Report

    Report Number
    1044475-2012-00161
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 22, 2012
    Manufacturer
    TELEFLEX
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: CUSTOMER ALLEGES: THE CLIP STUCK TO THE FORCEPS DURING SURGERY. NO DAMAGE TO THE PT AND NO CLIP FELL INTO THE PT. CUSTOMER STATED THAT THE HEMOLOK IS A NEW PRODUCT AND THEY DID NOT GET IT TO WORK. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEMOLOK TAKEAPART XL 10MM ENDO APPLIER ENDO APPLIER FZP TELEFLEX 1200590-001

    Patients

    Seq Age Sex Outcome Treatment
    1