BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES BRONCHOFIBERSCOPE

    MDR report key: 7693053 · Received July 17, 2018

    Report

    Report Number
    8010047-2018-01353
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Report Date
    August 23, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) SENT THE SUBJECT DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING AND THE TESTING INDICATED NO MICROBIAL GROWTH FOR SAMPLES TAKEN FROM THE DISTAL END AND THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE. AFTER THE MICROBIOLOGICAL TESTING AT THE THIRD PARTY LABORATORY, THE EVALUATION OF THE SUBJECT DEVICE BY (B)(4) CONFIRMED FOLLOWING. MANY IMAGE (IG) FIBERS WERE BROKEN. THERE WERE KINK AND TWIST ON THE UNIVERSAL CORD. THE PARTS OF THE COATING ON THE INSERTION TUBE AND THE UNIVERSAL CODE WERE PEELING OFF. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. OMSC REVIEWED THE MANUFACTURE HISTORY OF THE DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS. THE DEVICE HAD BEEN CLEANED WITH NON-OLYMPUS BRUSH (US ENDOSCOPY) AND REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSER, SOLUSCOPE SERIE 3. THE USER ALSO REPORTED THAT THERE WAS A CRUSHING IN THE TUBE OF THE DEVICE. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535246 OES BRONCHOFIBERSCOPE BRONCHOFIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-P60

    Patients

    Seq Age Sex Outcome Treatment
    1