BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS RHINO-LARYNGOFIBERSCOPE

    MDR report key: 2061063 · Received April 8, 2011

    Report

    Report Number
    8010047-2011-00073
    Event Type
    Other
    Date Received
    April 8, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    CAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY CONTACT INDICATED THAT THEY WERE IMPLEMENTING A PLAN TO FOLLOW THE MANUFACTURER'S RECOMMENDATIONS FOR REPROCESSING OF ENDOSCOPES. OLYMPUS HAS FOLLOWED-UP WITH THE USER FACILITY TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, AND TO OFFER IN-SERVICE TRAINING REGARDING THE APPROPRIATE REPROCESSING OF ENDOSCOPES, HOWEVER, THE USER FACILITY HAS NOT YET RESPONDED. THE DEVICE REFERENCED WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. BASED UPON THE INFORMATION PROVIDED BY THE USER FACILITY, THE CAUSE OF THE PHENOMENON APPEARS TO BE FAILURE TO REPROCESS THE DEVICES IN ACCORDANCE WITH THE DIRECTIONS FOR USE. OLYMPUS WILL CONTINUE TO FOLLOW-UP WITH THE USER FACILITY TO PROVIDE ASSISTANCE. IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME, THEN THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED BY THE USER FACILITY THAT THE SUBJECT DEVICE HAD NEVER BEEN COMPLETELY SUBMERGED INTO CLEANING SOLUTION DURING REPROCESSING. ONLY THE FLEXIBLE PORTION OF THE ENDOSCOPE WAS SAID TO BE REPROCESSED IN DISINFECTANT SOLUTION. THERE WERE NO REPORT OF INFECTION OR CROSS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS RHINO-LARYNGOFIBERSCOPE RHINOLARYNGOSCOPE CAL OLYMPUS MEDICAL SYSTEM CORPORATION ENF-P4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1