BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 6471117 · Received April 7, 2017

    Report

    Report Number
    8010047-2017-00402
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    February 25, 2017
    Report Date
    March 3, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K131780
    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" AND "PMA/510(K) NUMBER".

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURE 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 BECOMES AVAILABLE OR IF THE DEVICE IS RETURNED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    AFTER THE USER FACILITY RECEIVED THE LOANER SUBJECT DEVICE FROM OBV, THE USER FACILITY REPROCESSED THE SUBJECT DEVICE USING WASSENBURG, A NON OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL, WITH MEDICLEAN FORTE AND SEPTO PAC (BOTH DR (B)(6)). AFTER THE REPROCESS, THE USER FACILITY CONDUCTED A SURVEILLANCE CULTURING. IN THE TEST, THE SUBJECT DEVICE TESTED POSITIVE FOR E. CLOACAE. AFTER THE POSITIVE CULTURE RESULT, THE USER FACILITY STOPPED USING THE SUBJECT DEVICE AND REPROCESSED AGAIN AND AGAIN. THE FACILITY ALSO INFORMED THAT THE SUBJECT DEVICE WAS RE-TESTED AND THE TESTING INDICATED NO MICROORGANISMS GROWTH FOR THE SUBJECT DEVICE. THE USER FACILITY USED THE SUBJECT SCOPE BETWEEN THE FIRST CULTURE AND RECEIVING THE TEST RESULT. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253984 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-HQ190

    Patients

    Seq Age Sex Outcome Treatment
    1