BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEAL INTUBATION FIBERSCOPE

    MDR report key: 6042696 · Received October 19, 2016

    Report

    Report Number
    8010047-2016-01302
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    May 31, 2016
    Report Date
    October 20, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K#: K981543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS ONCE RETURNED TO OCM, HOWEVER, IT WAS RETURNED TO THE FACILITY AS IT WAS BECAUSE NO ANOMALY WITH THE SUBJECT DEVICE WAS DETECTED. NO MALFUNCTION OF THE SUBJECT DEVICE WAS AFTERWARDS REPORTED BY THE FACILITY. THE EXACT CAUSE OF THE EVENT HAS NOT BEEN DETERMINED AT THIS TIME. IF ADDITIONAL AND IMPORTANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    WHEN THE SUBJECT DEVICE WAS INSERTED INTO THE PATIENT'S TRACHEA IN AN EXAMINATION, IT BECAME IMPOSSIBLE TO STRAIGHTEN THE BENDING SECTION EVEN AFTER TURNING THE ANGULATION CONTROL LEVER TO THE NEUTRAL POSITION. THE USER FACILITY SUSPENDED THE EXAMINATION. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS REPAIRED BY (B)(4), A SERVICE CENTER OF OLYMPUS IN (B)(4), ON JUNE 21, 2016. DURING THE REPAIR, WATER LEAKAGE OF THE INSERTION PORTION AND SUCTION CHANNEL, AND DAMAGE OF THE LIGHT GUIDE WERE CONFIRMED. THE USER FACILITY REPORTED THE ABOVE EVENT TO (B)(6) IN (B)(4) ON JUNE 24, 2016 AFTER RECEIVING THE REPAIRED SUBJECT DEVICE. THE SUBJECT DEVICE WAS RETURNED TO OCM, OLYMPUS SALES AND SERVICE COMPANY OF OLYMPUS IN (B)(4), FOR RE-MAINTENANCE. IT WAS RETURNED TO THE USER FACILITY AS IT WAS ON JULY 12, 2016 BECAUSE NO ANOMALY WITH THE SUBJECT DEVICE WAS DETECTED. (B)(6) IN (B)(4) REPORTED TO (B)(6) IN (B)(4) ABOUT THE EVENT OF UNCONTROLLABLE ANGULATION AND OCM BECAME AWARE THE EVENT ON 22 SEPTEMBER, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691095 TRACHEAL INTUBATION FIBERSCOPE TRACHEAL INTUBATION FIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. LF-GP N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR