BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 7103517 · Received December 11, 2017

    Report

    Report Number
    8010047-2017-01955
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    October 13, 2017
    Report Date
    December 11, 2017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    PMA / PMN Number
    PK100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. BUT WAS RETURNED TO OLYMPUS (B)(4). FOLLOWING ADDITIONAL HIGH LEVEL DISINFECTION AT (B)(4), THE SUBJECT DEVICE WAS SENT TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, THE TESTING INDICATED NO MICROBIAL GROWTH FOR THE SUBJECT DEVICE. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, PSEUDOMONAS LUTEORA AND STENOTROPHOMONAS MALTOPHILIA (>100CFU/SCOPE) WERE DETECTED FROM THE SUBJECT DEVICE. THE CUSTOMER REPORTED THAT THE SUBJECT DEVICE WAS REPROCESSED ACCORDING TO THE INSTRUCTION MANUAL. THE SUBJECT DEVICE HAD BEEN DISINFECTED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSR MODEL ETD3 (NOT AVAILABLE IN THE U.S.) WITH PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885903 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H180AI

    Patients

    Seq Age Sex Outcome Treatment
    1