BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA BRONCHOVIDEOSCOPE

    MDR report key: 12257674 · Received August 2, 2021

    Report

    Report Number
    8010047-2021-09627
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Report Date
    September 22, 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 WEAR OF THE ADHESIVE AROUND THE OBJECTIVE LENS AND THE LIGHT GUIDE LENS FROM THE PHOTOS PROVIDED BY OLYMPUS KOREA CO., LTD. (OKR). IN ADDITION, OMSC CONFIRMED THE RESULT OF THE DEVICE INSPECTION, BUT COULD NOT IDENTIFY ANY DEFECTS THAT COULD AFFECT THE OCCURRENCE OF THE REPORTED EVENT. BASED UPON THE PAST SIMILAR CASES, THE REPORTED EVENT MAY HAVE BEEN CAUSED BY THE FOLLOWING EFFECTS, ETC.: PHYSICAL STRESS; CHEMICAL STRESS; POOR STORAGE ENVIRONMENT (DIRECT SUNLIGHT, HIGH TEMPERATURE, HIGH HUMIDITY, ENVIRONMENT EXPOSED TO X-RAYS AND ULTRAVIOLET RAYS, ETC.). OMSC DETERMINED THAT THE REPORTED EVENT COULD BE PREVENTED BECAUSE THE INSTRUCTION MANUAL PROVIDES PRECAUTIONS REGARDING THE HANDLING OF THE INSERTION TUBE AND STORAGE OF THE DEVICE. SIMILAR EVENTS HAVE OCCURRED IN THE PAST AT THE USER FACILITY. 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 OKR. OKR INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING: THE BENDING SECTION RUBBER WAS BROKEN. THERE WAS A LEAKAGE DUE TO THE BROKEN BENDING SECTION RUBBER. THE LIGHT GUIDE LENS WAS SCRATCHED AND WORN. 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

    THE USER FACILITY RETURNED THE DEVICE TO OLYMPUS (B)(4) BECAUSE IT FOUND A LEAKAGE FROM THE INSERTION SECTION DURING THE PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. OKR THEN INSPECTED THE DEVICE AND FOUND THAT THE COATING OF THE INSERTION TUBE GREATER THAN 1X1 SQUARE MILLIMETER WAS PEELED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156253 EVIS LUCERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T260

    Patients

    Seq Age Sex Outcome Treatment
    1