BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED 5MM AUTOMATIC CLIP APPLIER

    MDR report key: 3231995 · Received July 15, 2013

    Report

    Report Number
    3003898360-2013-00296
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 28, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RECEIVED BY MFR. PER DEVICE HISTORY REPORT (DHR) REVIEW INVESTIGATION DID NOT 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. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: THE CLIP APPLIER WOULD NOT LOAD APPROPRIATELY. THE POLYMER CLIP WOULD GET STUCK HALF WAY LOADED INTO THE JAWS AND THEN AFTER PULLING THE TRIGGER ALL THE WAY, IT WOULD RELEASE INTO THE PT ABDOMEN. IT APPEARS AS THOUGH THE RATCHET FUNCTION IS NOT WORKING PROPERLY TO LOAD THE CLIP FULLY INTO THE JAWS. NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327671 CONMED 5MM AUTOMATIC CLIP APPLIER CLIP APPLIER FZP TELEFLEX MEDICAL 01B1300148

    Patients

    Seq Age Sex Outcome Treatment
    1