BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRA IRRIGATION SYSTEM

    MDR report key: 5008543 · Received August 14, 2015

    Report

    Report Number
    3007591333-2015-00035
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 22, 2015
    Report Date
    August 14, 2015
    Manufacturer
    ENDOCHOICE INC.
    Product Code
    FEQ
    PMA / PMN Number
    K133747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYDRA IRRIGATION TUBING SET WAS IN USE WITH A MEDIVATORS 24-HOUR CONNECTOR, WHICH DOES NOT INCLUDE A CHECK VALVE. THEREFORE THE ONLY BACK FLOW VALVE WAS ON THE HYDRA IRRIGATION TUBING SET. IT WAS DETERMINED UPON TESTING OF THE RETURNED DEVICE THAT THE VALVE DID NOT FUNCTION PROPERLY. SUBSEQUENT TESTING OF THIS LOT FOUND NO OTHER UNITS EXHIBITING THIS ISSUE. ENDOCHOICE HAS RECOMMENDED TO THE SITE THAT THEY UTILIZE SINGLE-USE CONNECTORS THAT INCLUDE BACK FLOW VALVES.

    Description of Event or Problem · 1

    A USER REPORTED THAT LIQUID GASTRIC CONTENTS BACK-FLOWED INTO THE IRRIGATION TUBING DURING A GASTROSCOPY. THERE WAS NO PATIENT IMPACT. AN OLYMPUS 190 GASTROSCOPE WAS IN USE WITH MEDIATORS ENDOGATOR 24-HOUR USE IRRIGATION PORT CONNECTOR AND THE ENDOCHOICE HYDRA IRRIGATION TUBING SET. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION THAT MEDICAL DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537603 HYDRA IRRIGATION SYSTEM PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE FEQ ENDOCHOICE INC. SIT-355 140520

    Patients

    Seq Age Sex Outcome Treatment
    1