BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED 5MM AUTOMATIC CLIP APPLIER

    MDR report key: 3881060 · Received April 8, 2014

    Report

    Report Number
    3003898360-2014-00210
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    February 26, 2014
    Report Date
    March 13, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW ANY 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. MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: COMPLAINT ALLEGES: CLIPS WOULD NOT CLOSE COMPLETELY. NO PATIENT INJURY REPORTED. PATIENT CURRENT CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210907 CONMED 5MM AUTOMATIC CLIP APPLIER CLIP APPLIER FZP TELEFLEX MEDICAL 01L1100308

    Patients

    Seq Age Sex Outcome Treatment
    1