BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 12737410 · Received November 2, 2021

    Report

    Report Number
    8010047-2021-13962
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Report Date
    November 2, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO SORC BUT HAS NOT BEEN RETURNED TO OMSC. SORC CHECKED THE SUBJECT DEVICE FOR EVALUATION. IT WAS CONFIRMED THAT THERE WAS A SIGN OF INSUFFICIENT OR INCORRECT REPROCESSING THE SUBJECT DEVICE WITH CLOGGING THE AIR/WATER NOZZLE. IN ADDITION, IT COULD SEE A PART OF FOREIGN OBJECT WAS COMING OUT FROM THE AIR/WATER NOZZLE. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE ROOT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE IDENTIFIED. HOWEVER BASED ON THE REPORT OF SORC, OMSC PRESUMED THERE WAS THE POSSIBILITY THIS PHENOMENON WAS ATTRIBUTED TO INSUFFICIENT REPROCESSING OR HANDLING FOR THE SUBJECT DEVICE BY THE USER. 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 THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC), IT WAS FOUND A SIGN OF INSUFFICIENT OR INCORRECT REPROCESSING THE SUBJECT DEVICE WITH CLOGGING THE AIR/WATER NOZZLE OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAD BEEN RETURNED FROM THE USER BECAUSE THE SUBJECT DEVICE HAD THE ZOOM/FOCUS MALFUNCTION. THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639587 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H290ZI

    Patients

    Seq Age Sex Outcome Treatment
    1