BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 13245258 · Received January 13, 2022

    Report

    Report Number
    8010047-2022-01372
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    November 22, 2021
    Report Date
    July 14, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FGB
    UDI-DI
    04953170403811
    PMA / PMN Number
    K181451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WILL BE RETURNED TO OLYMPUS FOR REPEAT CULTURES AND PHYSICAL EVALUATION/INSPECTION. THE DEFINITIVE CAUSE IF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT D3 AND G1 MANUFACTURER INFORMATION TO AIZU OLYMPUS CO., LTD. IN THE INITIAL AND SUPPLEMENTAL 01 REPORTS. IN ADDITION, THIS REPORT IS TO CORRECT THE MFR REPORT NUMBER OF THE INITIAL AND SUPPLEMENTAL 01 SUBMITTED UNDER THE MFR. REPORT TO THE CORRECT MFR REPORTING REGISTRATION NUMBER TO 9610595.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION, THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT. AFTER THE DEVICE WAS RETURNED TO OLYMPUS, IT WAS SENT OUT FOR ADDITIONAL TESTING. THE MICROBIOLOGICAL ANALYSIS REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED AND RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATION BETWEEN THE EVENT AND THE DEVICE COULD NOT BE CONFIRMED. THOUGH LOWER THAN THAT STANDARD VALUE, GROWTH WAS CONFIRMED AFTER REPROCESSING IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THIS INFORMATION IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): "REPROCESSING MANUAL: 1.4 PRECAUTIONS: WARNING: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM. " THREE ATTEMPTS WERE PERFORMED TO OBTAIN THE CLEANING, DISINFECTION, AND STERILIZATION CHECKLIST BUT WERE NOT SUCCESSFUL. IF ADDITIONAL INFORMATION IS OBTAINED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS DURING ROUTINE MICROBIOLOGICAL TESTING ON AN URETERO-RENO FIBERSCOPE (AS REQUIRED BY (B)(6) REGULATIONS, THE CUSTOMER DETECTED UNEXPECTED CONTAMINATION. THERE WAS NO PATIENT IMPACT RELATED TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    ONE COLONY FORMING UNITS (CFUS) WAS CONFIRMED FROM THE CHANNEL RINSING WATER IN CULTURE TESTING BY THE USER AFTER REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331854 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB AIZU OLYMPUS CO., LTD. URF-P7 04953170403811

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown