BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS

    MDR report key: 171276 · Received June 5, 1998

    Report

    Report Number
    8010047-1998-00018
    Event Type
    Other
    Date Received
    June 5, 1998
    Date of Event
    March 1, 1998
    Report Date
    May 8, 1998
    Manufacturer
    OLYMPUS OPTICAL CO., LTD.
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROBLEMS AT HOSP WERE OBSERVED BEGINNING ON MARCH 2, 1998. AT OR AROUND THIS DATE, A PT, WITH EXISTING MYCOBACTERIUM AVIUM INTRACELLULARE (MAI), WAS SCHEDULED FOR A DIAGNOSTIC BRONCHOSCOPY PROCEDURE. AN OLYMPUS BRONCHOSCOPE, BF-P20D, WAS USED FOR THE DIAGNOSTIC EXAM. FOLLOWING PROCEDURE, BF-P20D WAS SENT TO A THIRD PARTY REPAIR FACILITY DUE TO FLAKING OF EXTERIOR PARTS OF SCOPE. ACCORDING TO REPAIR FACILITY'S REPORT, FLAKING MATERIAL, DESCRIBED AS BLACK PARTICLES, WAS REPORTEDLY INSIDE CHANNEL OF SCOPE WAS WELL. INFECTION CONTROL COORDINATOR REPORTED THAT THIS BRONCHOSCOPE WAS USED ONLY FOR PT WITH EXISTING MYCOBACTERIUM AVIUM INTRACELLULARE. SHORTLY AFTER PROCEDURE, HOSP PULMONOLOGIST REPORTED TO INFECTION CONTROL COORDINTOR THAT THERE WAS AN UNUSUAL NUMBER OF PTS WITH MYCOBACTERIUM AVIUM INTRACELLULARE (MAI) AND PSEUDOMONAS AERUGINOSA. IN TOTAL, THERE WERE SEVEN REPORTS OF MAI AND YET UNDETERMINED NUMBER OF REPORTS OF PSEUDOMONAS. BRONCHOSCOPE MODELS BF-P20D, AND A BF-IT30 WERE USED FOR ALL DIAGNOSTIC PT PROCEDURES EXCEPT FOR FIRST PT PROCEDURE, DESCRIBED ABOVE AND TWO ADD'L PROCEDURES. BF-P20D (2800102) CULTURED NEGATIVE FOR MAI AND PSEUDOMONAS. MAI AND PSEUDOMONAS WERE DETECTED THROUGH ROUTINE CULTURES TAKEN DURING DIAGNOSTIC EXAMS IN THOSE PTS SCOPED WITH BRONCHOSCOPE MODELS BF-P20D AND A BF-IT30. TO DATE, ONLY PT IS IN ICU. HOSP REPORT-THERE ARE TWO CHARACTERIZATIONS OF INVESTIGATION AT HOSP. FIRST CHARACTERIZATION, PROVIDED BY HOSP INFECTION CONTROL COORDINATOR, IS PROVIDED BELOW. ACCORDING TO INFECTION CONTROL COORDINATOR, BF-P20D, ALSO EXHIBITED SIGNS OF FLAKING OF BLACK PARTICLES. HOWEVER, THIS SCOPE, AS PREVIOUSLY MENTIONED, USED FOR ALL PT PROCEDURES WITH NEW CASES OF MYCOBACTERIUM AVIUM INTRACELLULAR AND PSEUDOMONAS, WAS NOT SENT FOR REPAIR SINCE IT WASN'T FLAKING AS BADLY AS THE BF-P20D. ACCORDING TO INFECTION CONTROL COORD, WHEN PROBLEMS WITH CONTAMINATION WERE OBSERVED, ONLY THE BF-P20D WAS CULTURED. CULTURING WAS PERFORMED BY FLUSHING THE BIOPSY CHANNEL AND INSERTION TUBE WITH STERILE SALINE SOLUTION FOLLOWING REPROCESSING IN STERIS. BRONCHOSCOPE'S GROWTH WAS POSITIVE FOR PSEUDOMONAS. TO DATE, CULTURES HAVE NOT GROWN FOR MAI. INFECTION CONTROL SUPERVISOR STATED THAT GROWTH OF MAI IS SLOWER THAN GROWTH FOR PSEUDOMONAS. BF-P20D, WAS REMOVED FROM SVC ON MAY 1, 1998 AS RESULT OF REPORTS OF MAI AND PSEUDOMONAS. STERIS SYS WAS REMOVED FROM SVC BUT HAS SINCE BEEN RETURNED. BRONCHOSCOPE WAS SUBSEQUENTLY RETURNED TO SVC ON 5/15/98. BF-P20D HAS BEEN REMOVED FROM SVC AND THE INFECTION CONTROL COORD REPORTED THAT REMOVAL OF SCOPE WILL MOST PROBABLY BE PERMANENT. ON 5/14/98, BF-P20D WAS STERILIZED IN THE STERIS SYS WITH STERIS TUBING. AFTER COMPLETION OF REPROCESSING CYCLE, STERILE SALINE SOLUTION WAS FLUSHED THROUGH CHANNEL AND IT WAS CULTURED FOR MAI AND PSEUDOMONAS. ON 5/18/98, IT WAS REPORTED THAT CULTURES FOR BF-P20D WERE NEGATIVE FOR PSEUDOMONAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS BRONCHOFIBERSCOPE EOQ OLYMPUS OPTICAL CO., LTD. BF-P20D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other