BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTT

    MDR report key: 303952 · Received November 8, 2000

    Report

    Report Number
    MW1020361
    Event Type
    Malfunction
    Date Received
    November 8, 2000
    Date of Event
    September 21, 2000
    Report Date
    November 8, 2000
    Manufacturer
    MEDIVATORS
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A BRONCHOSCOPE WAS USED ON A PT WITH CONFIRMED CASE OF TUBERCULOSIS. THE NEXT BRONCHOSCOPY WAS DONE FOUR DAYS LATER. THAT PT CAME UP POSITIVE FOR MYOCOBACTERIUM TUBERCULOSIS COMPLEX. TWO ADD'L PTS WERE DONE. ONE ON THE 3 DAYS AFTER SECOND PT AND ONE THE FOLLOWING DAY WHO WERE NEGATIVE FOR MTB. THEN ANOTHER PT WAS DONE ON THE LAST DAY WHO CAME UP POSITIVE FOR MTB COMPLEX. CDC HAS BEEN NOTIFIED, IS PERFORMING DNA TESTING AND MAKING CARE RECOMMENDATIONS. NOT SURE IF BRONCHOSCOPE WAS CONTAMINATED OR IS A CLEANING/DISINFECTION PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTT SCOPE WASHER FEB MEDIVATORS ED-106 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other