BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS TRACHEAL INTUBATION FIBERSCOPE

    MDR report key: 2507509 · Received March 21, 2012

    Report

    Report Number
    8010047-2012-00081
    Event Type
    Other
    Date Received
    March 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EQN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAD CONTACTED THE USER FACILITY TO ARRANGE AN IN-SERVICE BUT THE USER FACILITY REPORTEDLY HAD DECLINED THE OFFER. THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST IS IN THE PROCESS OF ATTEMPTING TO F/U WITH THE USER FACILITY AGAIN, AND THIS REPORT WILL BE SUPPLEMENTED IF SIGNIFICANT AND RELEVANT INFO BECOMES AVAILABLE AT A LATER TIME. NO PRODUCT WAS RETURNED TO OLYMPUS FOR EVAL. OLYMPUS INSTRUCTION AND/OR REPROCESSING MANUALS PROVIDE DETAILED INFO ON HOW TO REPROCESS THE SUBJECT ENDOSCOPE. THE CAUSE OF THIS REPORT APPEARS TO BE DUE TO USER ERROR. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE USERS WERE NOT REPROCESSING THE REFERENCED DEVICE PRIOR TO USAGE. THERE WAS NO REPORT OF INFECTION OR PT CROSS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS TRACHEAL INTUBATION FIBERSCOPE TRACHEAL INTUBATION FIBERSCOPE EQN OLYMPUS MEDICAL SYSTEMS CORP. LF-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1