BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 8434989 · Received March 19, 2019

    Report

    Report Number
    8010047-2019-01326
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Report Date
    May 16, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. DURING THE EVALUATION, OMSC CONFIRMED THAT THERE WERE SCRATCHES ON THE UNIVERSAL CORD. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT. THE SUBJECT DEVICE HAS BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. IN THE EVALUATION, NO ABNORMALITY SUCH AS BUCKLING, SCRATCH, SMEAR OR FOREIGN MATERIAL WAS FOUND INSIDE OF THE INSTRUMENT CHANNEL AND THE SUCTION CHANNEL. NO SMEAR, FOREIGN MATERIAL OR SCRATCH WAS FOUND AT THE INSTRUMENT CHANNEL PORT, THE SUCTION CYLINDER, AND THE DISTAL END. 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.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. AS THE EVALUATION IS IN PROGRESS, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. 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 ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE AIR/WATER CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, ENDOCLENS (JOHNSON & JOHNSON), USING PHTHARAL. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225519 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H290ZI

    Patients

    Seq Age Sex Outcome Treatment
    1