BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1193450 · Received October 8, 2008

    Report

    Report Number
    8010047-2008-00170
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    July 30, 2008
    Report Date
    September 10, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INTERNAL CHANNELS OF THE DEVICE WERE EXAMINED AND MINOR SCRAPE MARKS WERE FOUND INSIDE THE INSTRUMENT CHANNEL NEAR THE DISTAL END. SLIGHT DEBRIS WAS NOTED INSIDE THE BIOPSY CHANNEL, CHANNEL MOUNT AND CYLINDERS. THE VARIABLE STIFFNESS WAS NOT WORKING PROPERLY DUE TO STRETCHED COIL WIRES, WHICH WAS ATTRIBUTED TO EXTENDED USE. IN ADDITION, THERE WAS A SMALL CHIP NOTED ON THE OBJECTIVE LENS, AND THE LIGHT GUIDE LENS WAS ALSO CHIPPED AND CRACKED. THERE WERE NICKS AND DENTS ON THE DISTAL END COVER AND BENDING SECTION CEMENT. AS PART OF THE INVESTIGATION INTO THIS MATTER, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST WILL VISIT THE FACILITY TO ASSES THE REPROCESSING PRACTICES AND TO PROVIDE NECESSARY TRAINING. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, USERS MAINTENANCE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT IN 2008 A TIP OF A CLEANING BRUSH WAS NOTED TO BE MISSING WHILE THE SUBJECT ENDOSCOPE WAS BEING MANUALLY CLEANED. AFTER EXAMINING THE CLEANING AREA, AND REPEATED BRUSHING OF THE INTERNAL CHANNELS OF THE ENDOSCOPE, THE TIP OF THE BRUSH WAS NOT LOCATED. THE ENDOSCOPE WAS THEN RETURNED TO SERVICE. THE FOLLOWING MONTH, THE SAME ENDOSCOPE WAS BEING MANUALLY DISINFECTED FOLLOWING A PROCEDURE, AND A TIP OF A CLEANING BRUSH BECAME DISLODGED FROM THE YOKE PORTION OF THE ENDOSCOPE. THE CLEANING TECHNICIAN AT THE USER FACILITY WAS SAID TO SUSPECT THAT THIS WAS A PORTION OF THE SAME CLEANING BRUSH THAT WAS LOST ON ORIGINAL DATE. AS PART OF THE FACILITY INVESTIGATION, THE TIP OF THE BRUSH WAS CULTURED AND THE RESULT WAS POSITIVE FOR "NORMAL FLORA, INCLUDES RARE AMOUNT THREE COLONY TYPES GRAM NEGATIVE RODS INCLUDING PSEUDOMONAS." THE FACILITY'S INTERIM RISK MANAGER REPORTED THAT A TOTAL PATIENTS HAD POTENTIALLY BE EXAMINED WITH THE SAME ENDOSCOPE FROM THE SAME DAY TO THE FOLLOWING MONTH. HOWEVER, THE INTERIM RISK MANAGER ALSO REPORTED THAT THERE WAS NO OBVIOUS INFECTIOUS DISEASE FOUND DURING AN INFECTION CONTROL REVIEW OF THE ASSOCIATED CASES AT THEIR FACILITY. THE INTERIM RISK MANAGER ALSO INDICATED THAT THEY DID NOT PERFORM MICROBIAL SAMPLING OF THE COLONOSCOPE, AS THE DEVICE HAD BEEN REPROCESSED MULTIPLE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION PCF-160AL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK