BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS TRACHEAL INTUBATION FIBERSCOPE

    MDR report key: 1713281 · Received June 3, 2010

    Report

    Report Number
    8010047-2010-00111
    Event Type
    Other
    Date Received
    June 3, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 17, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY REGARDING THIS REPORT. THE USERS REPORTED THE SAME BRONCHOSCOPE THAT WAS USED DURING THE BRONCHOSCOPY PROCEDURES ON SIX PTS, HOWEVER, THE SUBJECT DEVICE HAS BEEN REFURBISHED AND SHIPPED TO THE FACILITY ON APRIL 30, 2010. AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO VISIT THE USER FACILITY TO ASSESS THE REPROCESSING METHODS. DURING THE VISIT, THE ESS NOTED SEVERAL DEVIATIONS FROM THE REPROCESSING INSTRUCTIONS PROVIDED IN THE DEVICE INSTRUCTIONS FOR USE. THE ESS HAS PROVIDED IN-SERVICE TRAINING ON THE APPROPRIATE REPROCESSING PROCEDURES WITH THE HOSP STAFF. THE USER FACILITY REPORTED TO HAVE RULED OUT THE BRONCHOSCOPES AS A POTENTIAL SOURCE OF THE PT CROSS-CONTAMINATION. THE EXACT CAUSE OF THE PHENOMENON COULD NOT BE DETERMINED, HOWEVER, INSUFFICIENT REPROCESSING CANNOT BE EXCLUDED AS A POTENTIALLY CONTRIBUTORY FACTOR. THE USER FACILITY HAS ELECTED NOT TO RETURN THE REFURBISHED BRONCHOSCOPE TO OLYMPUS FOR EVALUATION. THE BRONCHOSCOPE WAS REPORTED TO HAVE BEEN REMOVED FROM SERVICE AND IS QUARANTINED AT THE USER FACILITY. REF MFR REPORT NUMBER 8010047-2010-00110 FOR A RELATED REPORT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO HAVE IDENTIFIED AN ADDITIONAL PT THAT UNDERWENT A BRONCHOSCOPY AT THE USER FACILITY AND TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. THE PT REPORTEDLY REMAINED HOSPITALIZED FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS TRACHEAL INTUBATION FIBERSCOPE TRACHEAL INTUBATION FIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORPORATION LF-TP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR SERIAL NUMBER UNK| CUSTOM ULTRASONICS AUTOMATIC ENDOSCOPE| REPROCESSOR, DEVICE MODEL UNK