BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 10506029 · Received September 9, 2020

    Report

    Report Number
    8010047-2020-06317
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Report Date
    October 12, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K131780
    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. SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), IT COULD NOT BE INVESTIGATED. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER BASED ON THE REPORT OF THE SERVICE DEPARTMENT OF OLYMPUS EUROPE SE & CO. KG (OEKG), OMSC SURMISED THERE WAS THE POSSIBILITY THIS PHENOMENON WAS ATTRIBUTED TO THE CLOGGING DUE TO THE CHEMICAL AGENT WHICH HAD BEEN USED AT THE PROCEDURES SUCH AS THE BIO-COMPATIBLE GLUE, THE SUBMUCOSAL INJECTION BY THE USER HANDLING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THE EVALUATION, 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 FROM THE USER THAT THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE WAS CLOGGED. AT THE INCOMING INSPECTION FOR THE REPAIR, THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) (OEKG) CHECKED THE SUBJECT DEVICE AND IDENTIFIED THE REPORTED PHENOMENON. THE SERVICE DEPARTMENT OF OEKG FOUND THAT THE CHEMICAL AGENT REMAINED INSIDE THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE. THAT CHEMICAL AGENT COULD NOT BE CLEANED AND REMOVED WITH THE CLEANING BRUSH. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976438 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-HQ190

    Patients

    Seq Age Sex Outcome Treatment
    1