BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 12022631 · Received June 18, 2021

    Report

    Report Number
    8010047-2021-07684
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Report Date
    July 14, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K181451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION. AFTER CONFIRMING THE REPORTED EVENT, AN ASP (ADVANCED STERILIZATION PRODUCTS) REPRESENTATIVE PROVIDED THE BOOSTER TO THE USER FACILITY AND IT WAS USED PROPERLY AT THE USER FACILITY. THE USER FACILITY BEGAN INVESTIGATING WHETHER THERE WAS AN EXPLANATION FROM THE ASP REPRESENTATIVE OR OLYMPUS REPRESENTATIVE, AND THE RECOGNITION OF THE STAFF IN CHARGE OF REPROCESSING. 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 · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). HOWEVER, BASED ON THE INFORMATION PROVIDED THAT THE USER FACILITY USED THE STERRAD 100S STERILIZATION SYSTEM MANUFACTURED BY JOHNSON & JOHNSON TO STERILIZE THE DEVICE WITHOUT ATTACHING THE BOOSTER (REF (B)(4)) THAT NEEDED TO BE CONNECTED TO THE DEVICE, OMSC DETERMINED THAT THE REPROCESSING PROCESS BY THE USER FACILITY MAY HAVE BEEN INAPPROPRIATE AND INSUFFICIENT. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST THE REPORTED FAILURE MODE. 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.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE OF OLYMPUS MEDICAL SCIENCE SALES CORP. CONFIRMED THAT THE USER FACILITY USED THE STERRAD 100S STERILIZATION SYSTEM MANUFACTURED BY JOHNSON & JOHNSON TO STERILIZE THE DEVICE WITHOUT ATTACHING THE BOOSTER (REF15400) THAT NEEDED TO BE CONNECTED TO THE DEVICE. THE USER FACILITY MAY HAVE BEEN STERILIZED ON A REGULAR BASIS WITHOUT THE BOOSTER FOR AT LEAST TWO YEARS. THERE WAS NO REPORT OF PATIENT INJURY AND INFECTION ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924560 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P7

    Patients

    Seq Age Sex Outcome Treatment
    1