BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS IRRIGATION TUBING FOR FLUSHING PUMP

    MDR report key: 2436204 · Received January 18, 2012

    Report

    Report Number
    9611174-2012-00002
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Report Date
    December 21, 2011
    Manufacturer
    KEYMED LTD.
    Product Code
    FEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORT, AND WAS INFORMED THAT THE NURSE DID NOT SUSTAIN INJURY AS A RESULT OF THE REPORTED INCIDENT. THE NURSE REPORTEDLY HAD TWO KNEE REPLACEMENT PRIOR TO THE REPORTED INCIDENT AND THE NURSE REPORTEDLY APPLIED COLD PACK ON HER KNEES AFTER THE INCIDENT, BUT DID NOT REQUIRE MEDICAL TREATMENT. THE NURSE IS REPORTEDLY DOING WELL. THE USER FACILITY PERSONNEL DISCARDED THE SUBJECT DEVICE FOLLOWING RECEIPT OF THE LETTER FROM OLYMPUS, AS OLYMPUS HAS INITIATED A CORRECTIVE ACTION TO ADDRESS COMPLAINTS ASSOCIATED WITH WATER LEAKING FROM THE IRRIGATION TUBING USED WITH THE OLYMPUS FLUSHING PUMP. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE IRRIGATION TUBING WAS LEAKING AND A NURSE HAD SLIPPED AND FALLEN DUE TO THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS IRRIGATION TUBING FOR FLUSHING PUMP IRRIGATION TUBING FOR OFP FEQ KEYMED LTD. OFP NA

    Patients

    Seq Age Sex Outcome Treatment
    1