BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OES CYSTONEPHROFIBERSCOPE

    MDR report key: 6878310 · Received September 20, 2017

    Report

    Report Number
    8010047-2017-01352
    Event Type
    Injury
    Date Received
    September 20, 2017
    Report Date
    September 20, 2017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    PMA / PMN Number
    PK032092
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. LOCAL SERVICE DIVISION OF OLYMPUS HAS CONTACTED THE USER FACILITY SEVERAL TIMES, BUT HAS NOT OBTAINED ANY ADDITIONAL INFORMATION. THE EXACT CAUSE COULD NOT BE DETERMINED AT PRESENT, IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE USER FACILITY SUSPECTED OF INFECTION IN SEVERAL PATIENTS AFTER USING THE SUBJECT DEVICE IN PROCEDURES. THERE WAS NO REPORT OF PATIENT OUTCOME ASSOCIATED WITH THIS REPORT. THE USER FACILITY REPORTED THAT THE SUBJECT DEVICE HAD BEEN REPROCESSED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL MINI ETD-2 (NOT AVAILABLE IN THE USA) AND THEY HAD NOT PERFORMED MANUAL CLEANING OF THE INSTRUMENT CHANNEL BEFORE DISINFECTING WITH MINI ETD-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660400 OES CYSTONEPHROFIBERSCOPE CYSTONEPHROFIBERSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CYF-5A

    Patients

    Seq Age Sex Outcome Treatment
    1