BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRONCHOFIBERSCOPE

    MDR report key: 7340585 · Received March 15, 2018

    Report

    Report Number
    8010047-2018-00444
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Report Date
    March 15, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    PK023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A SURVEILLANCE CULTURING TEST ON (B)(6) 2018 BY THE FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR CANDIDA GLABRATA (3CFU/PLATE) AND CANDIDA PARAPSILOSIS (3CFU/PLATE). IT WAS ALSO INFORMED THAT THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA (1CFU/PLATE) AND CANDIDA PARAPSILOSIS (1CFU/PLATE) IN THE ADDITIONAL SURVEILLANCE TEST ON (B)(6) 2018. THE SUBJECT DEVICE HAD BEEN DISINFECTED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL MINIETD2 (NOT AVAILABLE IN THE U.S.) WITH PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183378 BRONCHOFIBERSCOPE BRONCHOFIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-PE2

    Patients

    Seq Age Sex Outcome Treatment
    1