BEUDAMED
    FDA Adverse Event Summary report: N

    MEDIVATORS ENDOGATOR

    MDR report key: 4093341 · Received September 16, 2014

    Report

    Report Number
    1651395-2014-00007
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MEDIVATORS
    Product Code
    OCX
    PMA / PMN Number
    K092429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDIVATORS SALES REPRESENTATIVE WORKS CLOSELY WITH THIS FACILITY AND RETURNED THE TUBING USED IN THE PROCEDURE TO MEDIVATORS FOR INVESTIGATION. MEDIVATORS QA EXAMINED THE RETURNED DEVICE AND WAS NOT ABLE TO DUPLICATE THE COMPLAINT. THE TUBESET PERFORMED ACCORDING TO SPECIFICATION. TO DATE, THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR ILLNESS. THIS POTENTIAL COMPLAINT WILL CONTINUE TO BE MONITORED WITHIN MEDIVATORS COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    THE CASE STATES THAT THE FACILITY NOTICED DEBRIS FLOATING IN THE ENDOSCOPE IRRIGATION WATER BOTTLE. THE WATER BOTTLE IS CONNECTED TO AN ENDOGATOR TUBESET WHERE THE BACKFLOW VALVE SUPPOSEDLY FAILED CAUSING FOREIGN MATTER TO GET IN. THIS WAS DISCOVERED IN THE AFTERNOON AFTER MULTIPLE PATIENT PROCEDURES HAD BEEN PERFORMED. THERE IS POTENTIAL FOR PATIENT CROSS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570903 MEDIVATORS ENDOGATOR ENDOSCOPE AND ACCESSORIES OCX MEDIVATORS 100130 744586

    Patients

    Seq Age Sex Outcome Treatment
    1