BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA COLONOVIDEOSCOPE

    MDR report key: 5317358 · Received December 22, 2015

    Report

    Report Number
    8010047-2015-01265
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    November 30, 2015
    Report Date
    March 24, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICE AND CONFIRMED THAT THERE WAS NO IRREGULARITY RELATED TO THE EVENT. THE EXACT CAUSE COULD NOT BE DETERMINED AT PRESENT, IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED OLYMPUS MEDICAL SYSTEMS; HOWEVER, IT WAS RETURNED TO OLYMPUS (B)(4) FOR EVALUATION. AFTER REPROCESSING WITH AN AUTOMATED REPROCESSOR ETD, THE DEVICE WAS SENT TO A THIRD PARTY LABORATORY OF A UNIVERSITY FOR MICROBIOLOGICAL TESTING. IN THE MICROBIOLOGICAL TESTING, THE AIR/WATER CHANNEL AND INSTRUMENT CHANNEL CULTURE TESTED (B)(6). IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE CHANNELS OF THE SUBJECT DEVICE TESTED POSITIVE FOR UNDESIRABLE BACTERIA (B)(6) DURING A ROUTINE INSPECTION. THERE WAS NO INFECTION REPORT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844357 EVIS EXERA COLONOVIDEOSCOPE COLONOVIDEOOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION PCF-H180AL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1