BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENICON SUCTION IRRIGATION SYSTEM

    MDR report key: 1040632 · Received May 7, 2008

    Report

    Report Number
    1064003-2008-08002
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 7, 2008
    Manufacturer
    GENICON
    Product Code
    GCX
    PMA / PMN Number
    K041967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD INSPECTION: THE HEALTH CARE PROVIDER IS REQUESTED TO GENTLY TUG ON THE SUCTION AND IRRIGATION VALVE CAPS PRIOR TO USE OF THE LOT NUMBERS NOTED ABOVE. IF THE DEVICE IS DEFECTIVE, THE CAP(S) WILL EASILY PULL FREE FROM THE HANDPIECE. ALL DEFECTIVE PRODUCT IS TO BE RETURNED TO THE MFR.

    Description of Event or Problem · 1

    THE CAPS ON THE TRUMPET VALVES OF THE SUCTION IRRIGATION DEVICES COULD FALL OFF, RESULTING IN THE MALFUNCTION OF THE SUCTION IRRIGATION DEVICE. THE DEVICE WILL NOT PERFORM AS INTENDED IF THE VALVE CAPS ARE REMOVED. NO PT INJURIES OR DEATHS HAVE OCCURRED. THE DEVICE WILL NOT PERFORM AS INTENDED, AND THE DEFECT IS EVIDENT WITHIN THE PACKAGE OR AS SOON AS IT IS TAKEN OUT OF THE PACKAGE, PRIOR TO USE IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENICON SUCTION IRRIGATION SYSTEM SUCTION IRRIGATION VALVE ASSEMBLY GCX GENICON 441071225

    Patients

    Seq Age Sex Outcome Treatment
    1