BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 15928776 · Received December 6, 2022

    Report

    Report Number
    9610595-2022-05007
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 8, 2022
    Report Date
    January 20, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170363672
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED, AND THE REPORTED ISSUES WITH THE E315 AND E3105 ERROR MESSAGES WERE SPORADIC FAILURES. THE FAILURE COULD NOT BE CONFIRMED, BUT ITS OCCURRENCE WAS LIKELY. ADDITIONAL ISSUES WERE IDENTIFIED DURING THE DEVICE EVALUATION: THE UNIT HAD CORROSION; THE CONTROL KOB HAD PLAY; THE LIGHT GUIDE LENS AND DISTAL SHEATH GLUE WERE CRACKED; THE CONTROL BODY FLUID HOLDER HAD CORROSION; THE LIGHT GUIDE TUBE HAD A MINOR BUCKLE; THE SCOPE CONNECTION HAD FLUID; AND SCRATCHES WERE FOUND IN MULTIPLE LOCATIONS ON THE DEVICE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE SUGGESTED PHENOMENON WAS PRESUMED TO HAVE BEEN DUE TO USER HANDLING OF THE DEVICE CAUSING AN AIR/WATER PORT LEAK, AND WATER INVADED THE DEVICE. DUE TO THE WATER INVASION, AN ABNORMALITY OF ELECTRICAL PARTS OCCURRED WHICH LED TO THE DISPLAYED ERROR MESSAGE TEMPORARILY AT THE USER FACILITY. THE USER CAN DETECT THE SUGGESTED EVENT PROPERLY BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE (IFU): ·INSPECTION OF THE ENDOSCOPIC IMAGE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS EXPERIENCING ERROR MESSAGE, E315 UNSUPPORTED SCOPE AND E3105 ON THE EVIS EXERA III COLONOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422874 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H190DL 04953170363672

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown