BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA COLONOVIDEOSCOPE

    MDR report key: 11819531 · Received May 13, 2021

    Report

    Report Number
    8010047-2021-06254
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Report Date
    July 5, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170202537
    PMA / PMN Number
    K001241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. NONCONFORMITY OF THE SUBJECT DEVICE, WHICH MAY AFFECT THE REPORTED EVENT, WAS NOT CONFIRMED VIA DEVICE INSPECTION RESULT OF OLYMPUS DEUTSCHLAND GMBH (ODE). DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO (B)(4). (B)(4) SENT THE DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLE COLLECTED FROM THE DISTAL END AND THE INSTRUMENT, THE AIR/WATER CHANNELS OF THE DEVICE. THE TESTING RESULT CLEARED THE (B)(6) GUIDELINE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. INSTRUMENT CHANNEL: UNSPECIFIED MICROBES (1 CFU/1ML). THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, INNOVA E4 CMS/DC (BTH/CANTEL), USING GLUTARALDEHYDE. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716919 EVIS EXERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-Q165I 04953170202537

    Patients

    Seq Age Sex Outcome Treatment
    1