BEUDAMED
    FDA Adverse Event Summary report: N

    DEFENDO Y-OPSY BIOPSY VALVE IRRIGATOR FOR OLYMPUS AND FUJINON GI ENDOSCOPES

    MDR report key: 3832277 · Received December 2, 2013

    Report

    Report Number
    1651395-2013-00002
    Date Received
    December 2, 2013
    Date of Event
    August 27, 2013
    Report Date
    November 26, 2013
    Manufacturer
    MEDIVATORS
    Product Code
    ODC
    PMA / PMN Number
    K110088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFENDO Y-OPSY IRRIGATOR IS INTENDED TO ENABLE SIMULTANEOUS IRRIGATION AND INSTRUMENTATION IN THE ENDOSCOPE'S BIOPSY CHANNEL ON OLYMPUS AND FUJINON GI ENDOSCOPES. IN THIS CASE A PEDIATRIC SCOPE WAS USED IN COMBINATION OF THE Y-OPSY VALVE AND ENDOGATORS TUBING 200230. AFTER THE PROCEDURE WAS PERFORMED, WHILE THE TECH WAS REMOVING THE TUBING AND DEFENDO VALVE, THEY NOTICED THAT BLOOD HAD PASSED THE LUER LOCK PORT AREA OF THE TUBING. PER PHONE CONVERSATION WITH THE SALES REP, WHO IS IN REGULAR CONTACT WITH THIS CUSTOMER, STATED THAT THIS FACILITY RECEIVES IN-SERVICES DONE EVERY 6 MONTHS. SHE STATED THIS IS A COMPETENT SITE AND THIS IS THE FIRST REPORT OF AN INCIDENT LIKE THIS FROM THE FACILITY. IT IS BELIEVED THAT THE POTENTIAL CONTAMINATION WAS RECOGNIZED IMMEDIATELY. THE SUSPECT PARTS 100303 BIOPSY VALVE AND 200230 ENDOGATER TUBING WERE THROWN AWAY AND WERE NOT USED FOR SUBSEQUENT PROCEDURES.

    Description of Event or Problem · 1

    GASTROSCOPY WAS PERFORMED USING A PEDIATRIC SCOPE AND THE SCOPE DIDN'T HAVE AN AUXILLIARY WATER JET PORT CONNECTION FOR FLUSHING. THE Y-OPSY CONNECTOR (100303) WAS USED TO CONNECT THE IRRIGATION TO THE BIOPSY PORT CONNECTION TO IRRIGATE THE SCOPE. AFTER THE CASE, THE TECH REMOVED THE TUBING (200230) AND Y-OPSY PORT AND NOTICED BLOOD AROUND TH LUER LOCK AND IN THE TUBING ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623640 DEFENDO Y-OPSY BIOPSY VALVE IRRIGATOR FOR OLYMPUS AND FUJINON GI ENDOSCOPES Y-OPSY CONNECTOR ODC MEDIVATORS 100303

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOGATOR TUBING 200230