BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS OES CYSTONEPHROFIBERSCOPE

    MDR report key: 1966504 · Received January 14, 2011

    Report

    Report Number
    8010047-2011-00012
    Event Type
    Other
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 16, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THREE PATIENTS WERE EXAMINED USING THE SAME CYSTOSCOPE. ONE OF THE PATIENTS WAS ORIGINALLY EXAMINED WITH THE CYSTOSCOPE ON (B)(6) 2010 AND ON (B)(6) 2010, AND THE CULTURE TEST RESULTS REPORTEDLY TESTED POSITIVE FOR ESCHERICHIA COLI AND EXTENDED SPECTRUM BETA-LACTAMASE ENZYME (ESBL). THE FOLLOWING DAY, TWO OTHER PATIENTS WERE EXAMINED TO HAVE SUSTAINED THE ESBL INFECTIONS. ONE OF THE PATIENTS WAS PROVIDED AN INTRAVENOUS ANTIBIOTIC, WHILE THE OTHER TWO PATIENTS WERE PROVIDED A SCRIPT TO TAKE MAYNARD ANTIBIOTIC. NO FURTHER INFO WAS PROVIDED BY THE USER FACILITY. THE DEVICE WAS SENT TO AN INDEPENDENT LABORATORY FOR MICROBIOLOGICAL TESTING PRIOR TO OLYMPUS PERFORMING A PHYSICAL EVAL OF THE DEVICE. THE RESULTS ARE STILL PENDING. AS PART OF OUR INVESTIGATION INTO THIS REPORT AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST WAS DISPATCHED TO THE USER FACILITY TO ASSESS THE FACILITY'S REPROCESSING PRACTICES AND PROVIDE REPROCESSING TRAINING IF NECESSARY. THE EXACT CAUSE OF THE PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED. IF ADD'L AND SIGNIFICANT INFO IS RECEIVED AT A LATER DATE, THIS REPORT WILL BE UPDATED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. THIS IS THREE OF THREE REPORTS, CROSS-REFERENCE MFR REPORT NUMBER: 8010047-2011-00011, AND 00011.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THREE PATIENTS DEVELOPED BLADDER INFECTIONS AFTER HAVING UNDERGONE CYSTOSCOPY PROCEDURES. THE USER FACILITY PERFORMED CULTURES ON THE SUBJECT DEVICE AND THE RESULTS WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS OES CYSTONEPHROFIBERSCOPE CYSTOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORPORATION CYF-5A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization