BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA BRONCHOVIDEOSCOPE

    MDR report key: 11490761 · Received March 16, 2021

    Report

    Report Number
    8010047-2021-03751
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    February 16, 2021
    Report Date
    December 20, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, KLEBSIELLA SERRATIA (<10 CFU) WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, BHT INNOVA OR STEELCO EW2, USING PERACETIC ACID. 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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE WAS EVALUATED AT OLYMPUS REPAIR CENTER. ACCORDING TO THE EVALUATION, THE FOLLOWING WAS FOUND. -IMAGE GUIDE TUBE HAD STRUCTURAL DETERIORATION THAT MAY CAUSE KINK. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) 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

    05-05-2021. THE USER FACILITY COMMENTED THAT THE FOLLOWING FIVE ENDOSCOPES WERE POSSIBLY INFECTED WITH KLEBSIELLA. BF-F260 (SN: (B(4), BF-F260 (SN: (B)(4), BF-P260F (SN: (B)(4), BF-UC260FW (SN: (B)(4), BF-UC260FW (SN: (B)(4). THE DOCTOR OF THE USER FACILITY HAS OPERATED A PROCEDURE USING THESE ENDOSCOPES FOR SOME PATIENTS. THE USER FACILITY CONFIRMED THAT A PATIENT WAS INFECTED WITH KLEBSIELLA. THE SOURCE OF THE INFECTION AND THE NUMBER OF INFECTED PATIENTS ARE UNKNOWN. OTHER DETAILED INFORMATION SUCH AS THE REPROCESSING METHOD WAS NOT PROVIDED. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) IS SUBMITTING FIVE MEDICAL DEVICE REPORTS ACCORDING TO THE NUMBER OF INFECTED ENDOSCOPES. THIS IS THE 2ND OF 5 REPORTS (REGARDING BF-F260, SN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389594 EVIS LUCERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-F260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other