BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 7836533 · Received August 31, 2018

    Report

    Report Number
    8010047-2018-01682
    Event Type
    Malfunction
    Date Received
    August 31, 2018
    Date of Event
    July 9, 2018
    Report Date
    March 3, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    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. 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 · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    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 STENOTROPHOMONAS MALTOPHILIA (>100CFU), ENTEROBACTER AEROGENES (>100CFU) DURING A ROUTINE SURVEILLANCE CULTURING TEST AT THE FACILITY. THE FACILITY DID NOT PROVIDE OTHER INFORMATION ON 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
    679746 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H185

    Patients

    Seq Age Sex Outcome Treatment
    1