BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS ENDOSCOPE REPROCESSOR

    MDR report key: 16537658 · Received March 14, 2023

    Report

    Report Number
    9610595-2023-04266
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    February 13, 2023
    Report Date
    May 31, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING, AND A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE THE DEVICE'S MANUFACTURING DATE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE FILTER REPLACEMENT ISSUE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE EVENT WAS CAUSED BY THE USER'S MISHANDLING OF THE WATER FILTER REPLACEMENT MANAGEMENT. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING VERBIAGE, WHICH MAY HAVE PREVENTED THE PHENOMENON: ¿REPLACE THE WATER FILTER AT LEAST ONCE A MONTH TO PREVENT CONTAMINATION OF THE RINSE WATER.¿. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE ENDOSCOPE REPROCESSOR FILTER THAT WAS USED TO CLEAN SCOPES WAS NOT REPLACED SINCE (B)(6) 2021. IT WAS NOTED, SCOPE (MODEL: GIF-XZ1200) WAS USED ON TWO TO THREE PATIENTS. HOWEVER, THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. PATIENT IDENTIFIERS: (B)(6) (2100657, GIF-XZ1200), (B)(6) (2100657, GIF-XZ1200), AND (B)(6) (2100657, GIF-XZ1200) CAPTURE COMPLAINTS ON THE SCOPE REPROCESSED BY THE SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834740 OLYMPUS ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB AIZU OLYMPUS CO., LTD. OER-6

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown