BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS FLUSHING PUMP

    MDR report key: 1360349 · Received April 10, 2009

    Report

    Report Number
    9611174-2009-00001
    Event Type
    Other
    Date Received
    April 10, 2009
    Report Date
    March 12, 2009
    Manufacturer
    SOUTHEND-ON-SEA
    Product Code
    FEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST AND SALES REPRESENTATIVE HAVE VISITED THE USER FACILITY AND PROVIDED IN-SERVICE TRAININGS TO HOSPITAL PERSONNEL ON PROPER REPROCESSING PRACTICES. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. REFERENCE MFR NUMBER: 8010047-2009-00067 FOR THE OTHER RELATED REPORT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE USER FACILITY HAD NOT PROPERLY REPROCESSED THE OFP FLUSHING PUMP WATER BOTTLE SINCE ITS INITIAL INTRODUCTION AND INSTALLATION IN MAY 2004. THE USER FACILITY IS CURRENTLY NOTIFYING (B)(6) PATIENTS THAT RECEIVED PROCEDURES DURING THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS FLUSHING PUMP FLUSHING PUMP FEQ SOUTHEND-ON-SEA OFP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other AN MAJ-855, AUXILIARY WATER TUBE, LOT# UNK