BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA BRONCHOVIDEOSCOPE

    MDR report key: 12322584 · Received August 16, 2021

    Report

    Report Number
    8010047-2021-10257
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Report Date
    September 2, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    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 THE DAMAGE AND DEFORMATION OF THE BENDING SECTION FROM THE PHOTOS PROVIDED BY OLYMPUS KOREA CO., LTD. (OKR). DEFECTS WERE IDENTIFIED FROM THE DEVICE EVALUATION RESULT, BUT NO DEFECTS AFFECTING THE REPORTED EVENT WERE IDENTIFIED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO OMSC. HOWEVER, BASED UPON THE PAST SIMILAR CASES, THE REPORTED EVENT MAY HAVE BEEN CAUSED BY THE APPLICATION OF SOME PHYSICAL OR CHEMICAL STRESS TO THE INSERTION SECTION. EXAMPLES INCLUDE PHYSICAL STRESS SUCH AS RUBBING THE INSERTION SECTION, CHEMICAL STRESS DUE TO DEVIATION FROM THE REPROCESSING MANUAL, AND POOR STORAGE ENVIRONMENT SUCH AS DIRECT SUNLIGHT, HIGH TEMPERATURE, HIGH HUMIDITY, X-RAYS AND ULTRAVIOLET RAYS, ETC. THE INSTRUCTION MANUAL PROVIDES WARNINGS ABOUT APPLYING EXTERNAL STRESS TO THE INSERTION SECTION, REPROCESSING METHOD NOT RECOMMENDED BY THE REPROCESSING MANUAL, AND STORAGE OF THE ENDOSCOPE IN A HARSH ENVIRONMENT. 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 WAS EVALUATED AT (B)(4) AS A RESULT OF THE EVALUATION, THE FOLLOWING WAS CONFIRMED. THE UPWARD ANGULATION WAS OUT OF THE STANDARD DUE TO THE WORN ANGLE WIRE. THE LIGHT GUIDE LENS WAS BROKEN. INSULATION RESISTANCE AT THE DISTAL END WAS OUT OF THE STANDARD DUE TO A PINHOLE IN THE BENDING SECTION RUBBER. THERE WAS A LEAKAGE FROM THE BENDING SECTION RUBBER DUE TO THE PINHOLE. THE ELECTRICAL CONNECTOR WAS CORRODED DUE TO A LEAKAGE. THE INSERTION TUBE WAS WRINKLED. 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) AND FOUND THAT THE COATING OF THE INSERTION TUBE GREATER THAN 1X1 SQUARE MILLIMETER WAS PEELED OFF. THIS DEVICE IS AN OLYMPUS ASSET AND THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224145 EVIS LUCERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-F260

    Patients

    Seq Age Sex Outcome Treatment
    1