BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 6947184 · Received October 13, 2017

    Report

    Report Number
    8010047-2017-01469
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 13, 2017
    Report Date
    March 3, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    PK100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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. FOLLOWING ADDITIONALLY DEFECTS HAVE BEEN DETECTED DURING (B)(4) INVESTIGATION. OBJECTIVE LENS SCRATCHED. DISTAL END COVER DAMAGED. CONNECTING TUBE SLIGHTLY SQUEEZED. ANGULATION SYSTEM WEAR AND TEAR. 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 DURING SURVEILLANCE CULTURING TEST BY THE FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA(>100CFU/ML). THE SUBJECT DEVICE HAD BEEN DISINFECTED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSR MODEL ETD-3 (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
    729381 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H180

    Patients

    Seq Age Sex Outcome Treatment
    1