BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEAL INTUBATION FIBERSCOPE

    MDR report key: 9108547 · Received September 24, 2019

    Report

    Report Number
    8010047-2019-03359
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Report Date
    October 23, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170340215
    PMA / PMN Number
    K981543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED, BUT IT IS SURMISED THAT EXCESSIVE FORCE WAS APPLIED TO THE INSERTION TUBE AND THE BENDING SECTION OF THE SUBJECT DEVICE.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE INTERNAL METAL PART WAS EXPOSED FROM THE BENDING SECTION OF SUBJECT DEVICE DURING AN INCOMING INSPECTION AT OLYMPUS REPAIR SERVICE CENTER. IN THE INCOMING INSPECTION, THE SUBJECT DEVICE FAILED THE LEAKAGE TEST. OTHER DETAILED INFORMATION SUCH AS WHEN THE EVENT OCCURRED WAS NOT PROVIDED FROM THE USER FACILITY. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907796 TRACHEAL INTUBATION FIBERSCOPE TRACHEAL INTUBATION FIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. LF-GP 04953170340215

    Patients

    Seq Age Sex Outcome Treatment
    1