BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOSCOPE

    MDR report key: 5995628 · Received October 3, 2016

    Report

    Report Number
    8010047-2016-01273
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    August 29, 2016
    Report Date
    December 13, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. MICROBIOLOGICAL TESTING FOR THE FLUSHING WATER OF THE ETD-2 WAS CONDUCTED BY THE FACILITY. IN THE TEST, THE FLUSHING WATER DID NOT GROW ANY MICROORGANISMS. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS (B)(4). HOWEVER, THE FACILITY ASKS FOR NEW SPECIAL BRUSHES (OTHER THAN REGULAR, LARGE ONES ) FOR THE SUBJECT DEVICE. OLYMPUS HAS REVISED THE REPROCESSING MANUAL OF THE TJF-145 (WHICH IS NOT MARKETED IN THE U.S.) AND IS PLANNING TO PROVIDE THE MAJ-1534 AS A NEW BRUSH FOR THAT DUODENOSCOPE. THE MAJ-1534 BRUSH IS ALREADY AVAILABLE IN THE U.S. AND IS REFERENCED IN THE REPROCESSING INSTRUCTIONS FOR THE TJF-160F/VF.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE COULD NOT BE DETERMINED AT PRESENT, IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING ROUTINE SURVEILLANCE CULTURING BY THE FACILITY, THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR ACINETOBACTER BAUMANNII (15CFU/50ML). THE FACILITY REPROCESSED THE SUBJECT DEVICE A SECOND TIME USING AN OLYMPUS AUTOMATED REPROCESSOR MODEL MINI ETD-2 WITH PERACETIC ACID. FOLLOWING THE SECOND REPROCESSING, THE SUBJECT DEVICE REPORTEDLY TESTED POSITIVE FOR 3 TYPES OF GRAM NEGATIVE BACTERIA INCLUDING ACINETOBACTER BAUMANNII. THE SUBJECT DEVICE WAS REPROCESSED IN THE ETD-2 WITH PERACETIC ACID A THIRD TIME AND THE FACILITY REPORTED POSITIVE CULTURES FOR THE SAME MICROORGANISMS. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645001 EVIS EXERA DUODENOSCOPE DOUDENOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORPORATION TJF-145 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 MINI ETD-2