BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEMOLOK ML CLIPS 6/CART 84/BOX

    MDR report key: 3013014 · Received February 25, 2013

    Report

    Report Number
    3003898360-2013-00075
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 6, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER DEVICE HISTORY REPORT (DHR) INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT. ASSESSMENT WAS CONDUCTED AND NO CHANGES REQUIRED. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. MFR WILL CONTINUE TO TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT DESCRIPTION: WHILE USING THE CLIPS ON THE APPLIER DURING SURGERY, THEY "BURST" SEVERAL TIMES. SURGEON THEN CHANGED CLIPS USING SAME APPLIER AND CONTINUED THE OPERATION. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80124 WECK HEMOLOK ML CLIPS 6/CART 84/BOX LIGATION CLIP GDO TELEFLEX MEDICAL 01H1100406

    Patients

    Seq Age Sex Outcome Treatment
    1