BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK BP TI SMALL 10/CART 180/BOX W/TAPE

    MDR report key: 3791821 · Received January 22, 2014

    Report

    Report Number
    3003898360-2014-00047
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    November 26, 2012
    Report Date
    December 30, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE. PER DEVICE HISTORY REPORT (DHR) INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT. 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: THE CUSTOMER REPORTS RECURRENT RELIABILITY ISSUES WITH THE CLIPS USED FOR THYROID SURGERY. THE ISSUE WOULD CONCERN THE CLIP APPLIER OR THE CLIP ITSELF. THE CLIP LEADS TO SLIP OFF VESSEL, BECAUSE IT IS NOT CLOSING PROPERLY, 2 OR 3 CLIPS ARE OFTEN USED TO OBTAIN A COMPLETE CLOSING. SOME CLIPS, OPENED OR CLOSED, ARE FOUND IN THE OPERATING FIELD. CLINICAL CONSEQUENCE REPORTED: FURTHER SURGERY IS NEEDED. COMPLAINT RECEIVED ONE YEAR AFTER THE EVENT OCCURRED. ADD'L INFO WAS REQUESTED: THE ONLY INFO AVAILABLE IS THAT THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53480 WECK BP TI SMALL 10/CART 180/BOX W/TAPE LIGATING CLIPS FZP TELEFLEX MEDICAL 01D1200460

    Patients

    Seq Age Sex Outcome Treatment
    1