BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS ENDOSCOPIC FLUSHING PUMP

    MDR report key: 2039374 · Received March 23, 2011

    Report

    Report Number
    9611174-2011-00002
    Event Type
    Death
    Date Received
    March 23, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 22, 2011
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
    Product Code
    FEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FIELD SVC ENGINEERS VISITED THE USER FACILITY AND INSPECTED THE SUBJECT DEVICE OF THIS REPORT, VERIFIED THAT IT OPERATED APPROPRIATELY, AND DID NOT NOTE ANY ANOMALIES WITH THE DEVICE. THE DEVICE WAS ALSO NOTED TO BE CONNECTED CORRECTLY TO OTHER EQUIPMENT IN THE VIDEO TOWER. OLYMPUS FOLLOWED-UP WITH THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADD'L INFO REGARDING THIS REPORT, HOWEVER, ONLY LIMITED INFO WAS PROVIDED REGARDING THE CIRCUMSTANCES OF THE EVENT. THE USER FACILITY HAS NOT YET RETURNED THE DEVICE FOR EVALUATION, BUT WAS SAID TO BE CONSIDERING DOING SO. OLYMPUS CONTINUES TO INVESTIGATE THIS REPORT. IF SIGNIFICANT ADD'L INFO BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. THIS REPORT IS ONE OF FOUR RELATED TO THE SAME EVENT. SEE ALSO 8010047-2011-00055, 8010047-2011-00056.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT APPROX THREE HOURS AFTER AN ERCP PROCEDURE, THE PT EXPIRED DUE TO AN AIR EMBOLISM. THE USER FACILITY INDICATED THAT THEY DID NOT BELIEVE THAT THE DEVICES OR THE PROCEDURE PERFORMED CAUSED THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ENDOSCOPIC FLUSHING PUMP FLUSHING PUMP FEQ KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. OFP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS TJF-160F DUODENOSCOPE, SERIAL # (B)(4)| OLYMPUS CV-160 VIDEO PROCESSOR, SERIAL # (B)(4)| OLYMPUS C1V-160 LIGHT SOURCE, SERIAL # (B)(4)