BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TJF-145-U

    MDR report key: 6488868 · Received April 12, 2017

    Report

    Report Number
    8010047-2017-00429
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    March 14, 2017
    Report Date
    February 22, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    PK954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS FOLLOWED UP THE FACILITY TO OBTAIN ADDITIONAL INFORMATION AND WAS INFORMED THAT THE SUBJECT DEVICE TESTED NEGATIVE IN THE ADDITIONAL MICROBIOLOGICAL TESTING AT THE FACILITY AFTER REPROCESSING WITH CAREFUL BRUSHING OF THE DISTAL END OF THE SUBJECT DEVICE AND INSTRUMENT CHANNEL FOLLOWED BY ETO GAS STERILIZATION. THE FACILITY ALSO REPORTED THAT THERE WAS NO IRREGULARITY IN THE ETD-4. HOWEVER, THE FACILITY DID NOT PROVIDE THE INVESTIGATION RESULTS OF THE ETD-3 AND THE WATER INLET OF THE AER. THIS IS ONE OF TWO REPORTS.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. AN OLYMPUS STAFF FOLLOWED UP WITH THE FACILITY TO ASSESS THE REPROCESSING PRACTICES AT THE FACILITY AND NOTED THAT AN INAPPROPRIATE BRUSH WAS USED AND WAS INFORMED THAT THE FACILITY WILL CONDUCT ADDITIONAL MICROBIOLOGICAL TEST FOR THE AER. 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 TEST BY THE FACILITY, THE TWO TJF-145 TESTED POSITIVE FOR UNDETERMINED BACTERIA. IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BEEN MANUALLY CLEANED WITH AN OLYMPUS BRUSH (MODEL MH-507) AND NON-OLYMPUS BRUSH (MODEL BS41221-G, UNKNOWN MANUFACTURE). THE SUBJECT DEVICE HAD BEEN REPROCESSED USING AN OLYMPUS AUTOMATED REPROCESSOR (AER) MODEL ETD-3 OR ETD-4 (NOT AVAILABLE IN THE USA). FOLLOWING THE CULTURING TEST FOR THE SUBJECT DEVICE, THE FACILITY CONDUCTED MICROBIOLOGICAL TEST FOR THE AER. IN THE TEST, INSIDE OF THE AER AND SAMPLE OF THE WATER INLET OF THE AER TESTED POSITIVE FOR UNDETERMINED BACTERIA. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT. THIS IS ONE OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268954 TJF-145-U DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-145

    Patients

    Seq Age Sex Outcome Treatment
    1