BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED AUTOMATIC APPLIER 5MM

    MDR report key: 1022661 · Received April 1, 2008

    Report

    Report Number
    3003898360-2008-00016
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 4, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER WILL MONITOR THIS ISSUE THROUGH TRENDING. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE, THE FIRST AND SECOND CLIP FIRED. HOWEVER, THE THIRD AND FOURTH SPUN SIDEWAYS THEN THE PUSHER ROD/SHAFT BROKE OFF AND LODGED IN THE TROCAR. THE PHYSICIAN WAS ABLE TO RETRIEVE THE PART. NO ADVERSE OUTCOME TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED AUTOMATIC APPLIER 5MM DISPOSABLE LIGATION CLIP APPLIER GDO TELEFLEX MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1