BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 11537192 · Received March 22, 2021

    Report

    Report Number
    8010047-2021-04008
    Event Type
    Injury
    Date Received
    March 22, 2021
    Date of Event
    February 16, 2021
    Report Date
    April 15, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PSV
    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. THE DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), BUT RETURNED TO OLYMPUS REPAIR CENTER FOR EVALUATION. ACCORDING TO THE EVALUATION, THE FOLLOWING WAS FOUND. -THE DISTAL END ADHESIVE WAS WORN. -THE DEVICE HAD A LEAKAGE. 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. 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G2 TO ADD THE FOREIGN COUNTRY UNITED KINGDOM. THIS MDR IS BEING SUBMITTED AS A RESULT OF A COMPLAINT RETROSPECTIVE REVIEW. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE FOLLOWING INFORMATION, A ROOT CAUSE COULD NOT BE DETERMINED: ·IN THE CULTURE TEST CONDUCTED BY THE LABORATORY AT THE REQUEST OF THE FACILITY, NO BACTERIA INFECTED BY THE PATIENT WAS DETECTED. ·IN THE INSPECTION OF THE DEVICES, REPAIR ITEMS WERE CONFIRMED FOR THE SUBJECT DEVICES. ·NO OBVIOUS DEVIATION FROM IFU WAS CONFIRMED FROM THE CDS-CHECKLIST. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    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

    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 5TH OF 5 REPORTS (REGARDING BF-UC260FW, SN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436579 EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV OLYMPUS MEDICAL SYSTEMS CORP. BF-UC260FW

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other