BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 11025082 · Received December 17, 2020

    Report

    Report Number
    8010047-2020-10526
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Report Date
    January 21, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONFIRMED THAT THERE WAS A BROWN PART AROUND THE LIGHT GUIDE LENS AND THERE WAS EVIDENCE OF FLOODING, FROM THE INSPECTION RESULT OF THE DEVICE BY OLYMPUS KOREA CO., LTD (OKR). IN ADDITION, THE LIGHT GUIDE LENS HAD MULTIPLE SCRATCHES AND CRACKS, AND THERE WAS EVIDENCE THAT THE LIGHT GUIDE LENS WAS PHYSICALLY STRESSED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS POSSIBILITY THAT THE REPORTED EVENT WAS CAUSED BY THE FOLLOWING; PHYSICAL STRESS. CHEMICAL STRESS. STORAGE ENVIRONMENT (DIRECT SUNLIGHT, HIGH TEMPERATURE, HIGH HUMIDITY, ENVIRONMENT EXPOSED TO X-RAYS AND ULTRAVIOLET RAYS, ETC.). AGING. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST THE REPORTED FAILURE MODE. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OKR FOR 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 INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) (OKR) AND FOUND THAT THERE WAS A GAP OF ADHESIVE ON THE DISTAL END OF THE DEVICE, AND STAIN ENTERED THE INSIDE OF THE LIGHT GUIDE LENS THROUGH THE GAP. THEREFORE, THE INSIDE OF THE LIGHT GUIDE LENS WAS DIRTY. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497412 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1