BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA BRONCHOVIDEOSCOPE

    MDR report key: 12686967 · Received October 24, 2021

    Report

    Report Number
    8010047-2021-13563
    Event Type
    Malfunction
    Date Received
    October 24, 2021
    Report Date
    December 3, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONFIRMED THE FOLLOWING FROM THE PHOTOS PROVIDED BY OLYMPUS KOREA CO., LTD. (OKR). -THE INSTRUMENT CHANNEL WAS CLOGGED WITH FOREIGN MATERIAL. -THE FOREIGN MATERIAL COMING OUT OF THE INSTRUMENT CHANNEL WAS SOLID AND PURPLISH. -THE INSERTION SECTION WAS SCRATCHED. OMSC CONFIRMED THE RESULT OF THE DEVICE EVALUATION, BUT COULD NOT IDENTIFY ANY DEFECTS THAT COULD AFFECT THE OCCURRENCE OF THE REPORTED EVENT. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE PAST SIMILAR CASES, THERE IS A POSSIBILITY THAT THE COATING OF THE INSERTION SECTION WAS PEELED OFF DUE TO THE FOLLOWING EFFECTS. -PHYSICAL STRESS -CHEMICAL STRESS -POOR STORAGE ENVIRONMENT (DIRECT SUNLIGHT, HIGH TEMPERATURE, HIGH HUMIDITY, ENVIRONMENT EXPOSED TO X-RAYS AND ULTRAVIOLET RAYS, ETC.) FROM THE DEVICE EVALUATION RESULTS, THE FOREIGN MATERIAL COMING OUT OF THE INSTRUMENT CHANNEL MAY NOT BE DERIVED FROM THE DEVICE, BUT FROM THE CHEMICALS USED DURING THE PROCEDURE OR REPROCESSING. IN ADDITION, BASED ON THE PAST SIMILAR CASES, THERE IS A POSSIBILITY THAT FOREIGN MATERIAL CAME OUT OF THE INSTRUMENT CHANNEL AND THE POORLY REPROCESSED DEVICE WAS USED IN THE PROCEDURE, BY THE FOLLOWING MECHANISM. -THE USER WAS IMPROPERLY REPROCESSING THE CHANNEL, BECAUSE TRAINING ON REPROCESSING FOR USER FACILITY STAFF WAS INSUFFICIENT. -THE CHEMICAL AGENT USED FOR THE PROCEDURE OR REPROCESSING REMAINED INSIDE THE INSTRUMENT CHANNEL AFTER THE DEVICE WAS REPROCESSED. -THE USER THEN INSPECTED THE DEVICE FOR USE IN THE PROCEDURE AND FOUND THAT THE CHANNEL WAS CLOGGED. -THE DEVICE WAS RETURNED TO OLYMPUS, AND WHEN OKR INSERTED A CLEANING BRUSH INTO THE INSTRUMENT CHANNEL, FOREIGN MATERIAL WAS PUSHED OUT OF THE INSTRUMENT CHANNEL OUTLET. OMSC DETERMINED THAT THE REPORTED EVENT COULD BE PREVENTED BECAUSE THE INSTRUCTION MANUAL PROVIDES PRECAUTIONS REGARDING THE HANDLING OF THE INSERTION TUBE, APPLYING OF THE MEDICAL-GRADE, WATER-SOLUBLE LUBRICANT TO THE INSERTION TUBE, STORAGE OF THE DEVICE, AND REPROCESSING THE CHANNEL. 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 · 0

    THE DEVICE WAS EVALUATED AT OLYMPUS (B)(4). AS A RESULT OF THE EVALUATION, THE FOLLOWING WAS CONFIRMED. -DUE TO WEAR OF THE ANGLE WIRE, THE UPWARD AND DOWNWARD ANGULATIONS WERE OUT OF SPECIFICATION. -THERE WAS A LEAKAGE FROM THE REMOTE SWITCH DUE TO DEFORMATION. -THE COLOR OF THE LIGHT GUIDE WAS DISCOLORED. -THERE WAS A GAP IN THE ADHESIVE OF THE BENDING SECTION RUBBER. OMSC CONFIRMED FROM MULTIPLE PHOTOGRAPHS PROVIDED BY (B)(4) THAT THE INSERTION TUBE WAS SCRATCHED AND THAT THE METAL INSIDE THE INSERTION TUBE WAS EXPOSED. 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 · 0

    THE USER FOUND THE SUCTION CHANNEL CLOGGED DURING THE PREPARATION FOR USE AND RETURNED THE DEVICE TO OLYMPUS (B)(4). (B)(4) THEN INSPECTED THE DEVICE AND FOUND THAT THE COATING OF THE INSERTION TUBE WAS PARTIALLY PEELED OFF. IN ADDITION, IT WAS FOUND THAT FOREIGN MATERIAL CAME OUT OF THE SUCTION CHANNEL. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) DETERMINED THAT THE POORLY REPROCESSED DEVICE WITH FOREIGN MATERIAL STUCK IN THE SUCTION CHANNEL MAY HAVE BEEN USED IN THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584815 EVIS LUCERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown