BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENTAX

    MDR report key: 257447 · Received January 4, 2000

    Report

    Report Number
    9610877-1999-00002
    Event Type
    Other
    Date Received
    January 4, 2000
    Date of Event
    June 1, 1999
    Report Date
    December 30, 1999
    Manufacturer
    ASAHI OPTICAL CO., LTD. MEDICAL INSTRUMENTS DIVISION
    Product Code
    EOQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT: OVER A TIME PERIOD OF SEVERAL MONTHS (FROM JUNE THROUGH OCTOBER 1999) UP TO 13 PTS HAVE BECOME CONTAMINATED WITH PSEUDOMONAS, A WATER-BORNE MICROORGANISM. A COMMON LINK WITH THESE PTS IS THEIR CONTACT WITH A PENTAX BRONCHOSCOPE REPROCESSED IN A STERIS SYSTEM 1 STERILIZER. FOUR PTS HAVE EXPIRED, HOWEVER, THESE DEATHS REPORTEDLY MAY OR MAY NOT BE DIRECTLY RELATED TO THIS "INFECTION OUTBREAK." DESPITE REPEATED REQUESTS, THE MEDICAL FACILITY HAS NOT PROVIDED ANY WRITTEN DOCUMENTATION DESCRIBING THIS EVENT IN DETAIL NOR HAVE THEY PROVIDED ANY WRITTEN REPROCESSING PROTOCOLS USED DURING THE TIME PERIOD IN QUESTION. TO DATE, THE FACILITY HAS REFUSED TO RETURN THE PENTAX BRONCHOSCOPE FOR EVAL. THE LACK OF CONCRETE DOCUMENTATION AND THE UNAVAILABILITY OF THE SUSPECT DEVICE FOR EVAL HAVE DELAYED THE SUBMISSION OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX BRONCHOSCOPE EOQ ASAHI OPTICAL CO., LTD. MEDICAL INSTRUMENTS DIVISION FB-15X *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other STERIS SYSTEM 1 STERILIZER.