BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA III VIDEO SYSTEM

    MDR report key: 3652379 · Received January 31, 2014

    Report

    Report Number
    2951238-2014-00038
    Event Type
    Other
    Date Received
    January 31, 2014
    Date of Event
    December 1, 2014
    Report Date
    January 13, 2014
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    FDF
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS STERILIZED AT THE USER FACILITY PRIOR TO BEING RETURNED TO OLYMPUS FOR EVAL. THE BIOPSY CHANNEL AND THE SUCTION CHANNEL WERE CHECKED WITH A BOROSCOPE, AND WHITE RESIDUE AND DEBRIS WERE FOUND THROUGHOUT. IN ADDITION, THE DISTAL END COVER WAS CRACKED WHICH CAUSED THE DEVICE TO FAIL THE INSULATION TEST. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. THIS REPORT WILL BE SUPPLEMENTED IF ADD'L AND RELEVANT INFO BECOMES AVAILABLE AT A LATER TIME. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO THE USER FACILITY TO OBSERVE THE USER FACILITY'S REPROCESSING PRACTICES. NO REPROCESSING DEVIATIONS WERE NOTED. PLEASE CROSS-REFERENCE THE FOLLOWING REPORTS FOR THE OTHER FOUR COLONOSCOPIES: 2951238-2014-00034, 2951238-2014-00035, 2951238-2014-00036 AND 2951238-2014-00037.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT FIVE COLONOSCOPIES TESTED POSITIVE FOR KLEBSIELLA, CITROBACTER, PSEUDOMONAS, STENOTROPHOMONAS, E.COLI, ENTEROCOCCUS AND OTHER NON-SPECIFIED GRAM NEGATIVE BACTERIA. THE USER FACILITY CULTURED THE DEVICE AS PART OF THEIR MICROBIOLOGICAL SURVEILLANCE TESTING. THE DEVICE WAS REPROCESSED IN A NON-OLYMPUS AUTOMATIC ENDOSCOPE REPROCESSOR PRIOR TO CONDUCTING THE TEST. THERE WAS NO PT INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66818 OLYMPUS EVIS EXERA III VIDEO SYSTEM ENDOSCOPIC VIDEO IMAGING SYSTEM FDF OLYMPUS AMERICA, INC. PCF-Q180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDIVATORS DSD EDGE| (AUTOMATIC ENDOSCPE REPROCESSOR)| SN # UNK