BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECH HEM-O-LOK XL ENDO 10, APPLIER

    MDR report key: 2771388 · Received September 26, 2012

    Report

    Report Number
    1044475-2012-00124
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    September 14, 2012
    Manufacturer
    TELEFLEX
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT DESCRIPTION: "THE CLIP APPLIER FAILED TO LOCK THE CLIP COMPLETELY. THIS PROBLEM WAS FOUND WHEN THE DEVICE WAS CHECKED PRIOR TO USE IN THE PROCEDURE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECH HEM-O-LOK XL ENDO 10, APPLIER ENDO APPLIER GDO TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1