BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 7761080 · Received August 8, 2018

    Report

    Report Number
    8010047-2018-01569
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Date of Event
    July 5, 2018
    Report Date
    August 28, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION.. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE SUBJECT DEVICE TESTED POSITIVE FOR FOLLOWING NUMBER OF BACTERIA DURING THE SURVEILLANCE CULTURING TEST AT THE USER FACILITY. ON (B)(6) 2018; ENTEROBACTER CLOACAE (1CFU/100ML). ON (B)(6) 2018; ENTEROBACTER CLOACAE (>67CFU/100ML). THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. BUT WAS RETURNED TO OLYMPUS (B)(4). THE SUBJECT DEVICE WAS SENT TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, THE TEST RESULT INDICATED NO MICROBIAL GROWTH FOR THE SUBJECT DEVICE. THE EXACT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. OMSC REVIEWED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE COULD NOT BE DETERMINED AT PRESENT. 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 SUBJECT DEVICE TESTED POSITIVE FOR UNSPECIFIED BACTERIA DURING A ROUTINE SURVEILLANCE CULTURING TEST AT THE FACILITY. THE FACILITY DID NOT PROVIDE OTHER INFORMATION ON THE NUMBER OF BACTERIA AND THE LOCATION WHERE THE BACTERIA DETECTED. IT WAS REPORTED THAT THE USER FACILITY HAD REPROCESSED USING A NON-OLYMPUS ENDOSCOPE REPROCESSOR (SOLUSCOPE S4) WITH PERACETIC ACID. THERE WAS NO REPORT OF PATIENT INFECTION ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606359 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-Q180AI

    Patients

    Seq Age Sex Outcome Treatment
    1