BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS BRONCHOSCOPE

    MDR report key: 1670185 · Received April 20, 2010

    Report

    Report Number
    8010047-2010-00075
    Event Type
    Other
    Date Received
    April 20, 2010
    Date of Event
    January 12, 2010
    Report Date
    March 23, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFO REGARDING THE REPORTED EVENT, BUT NO DETAILED INFO WAS PROVIDED. THE DEVICE REFERENCED IN THIS REPORT HAD BEEN RETURNED TO OLYMPUS FOR EVAL AND SERVICE ON FEBRUARY 22, 2010, WITH NO ALLEGATION OF POTENTIAL IMPACT TO PTS OR USERS AT THE TIME OF THE INITIAL REPORT. THE EVAL OF THE DEVICE CONFIRMED THAT THE CLEAR COATING ON THE INSERTION TUBE WAS PEELING AND FLAKING, WHICH APPEARED TO BE CONSISTENT WITH CHEMICAL DAMAGE. IN ADDITION, THERE WERE KINKS AND BUCKLES FOUND ON THE INSERTION TUBE. THE BENDING SECTION COVER GLUE WAS DISCOLORED. THE DEVICE HAS NOW BEEN REFURBISHED. AN OLYMPUS REPRESENTATIVE HAS VISITED THE USER FACILITY TO PROVIDE A REPROCESSING IN-SERVICE. OLYMPUS HAS BEEN INFORMED THAT THE USER FACILITY HAD PURCHASED A NEW AUTOMATED ENDOSCOPE REPROCESSOR (AER) TO REPLACE THE AER THAT THE FACILITY HAD BEEN USING IN THE PAST. THE CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE REPROCESSING METHOD EMPLOYED ON THE DEVICE COULD NOT BE RULED OUT AS CONTRIBUTORY FACTOR TO THE REPORTED PHENOMENON. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT STATING: "PEDIATRIC FLEXIBLE BRONCHOSCOPES (BOTH OLYMPUS, MODEL # BFXP160F), DURING PRE-USE AND CLEANING INSPECTION, NOTICED FLAKING AND PEELING OF THE OUTER SHEATH OF THE BRONCHOSCOPE INSERTION TUBE (SIMILAR TO PREVIOUS REPORTS WE HAVE FILED). STERIS SYSTEM 1 WAS THE DEVICE USED TO CLEAN THE SCOPES. PAST INVESTIGATIONS LED TO SUSPICION OF PERACETIC ACID BEING THE MOST PROBABLE CULPRIT. IF THIS FLAKING/PEELING WAS NOT DETECTED PRIOR TO USE ON A PT, IT IS POSSIBLE THAT A PIECE COULD BREAK AND LODGE IN PT'S LUNGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS BRONCHOSCOPE BRONCHOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORPORATION BF-XP160F NA

    Patients

    Seq Age Sex Outcome Treatment
    1