BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEAL INTUBATION FIBERSCOPE

    MDR report key: 11938678 · Received June 4, 2021

    Report

    Report Number
    8010047-2021-07100
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Report Date
    June 4, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K981543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC). SORC CHECKED THE SUBJECT DEVICE AND CONFRMED THE REPORTED EVENT. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM SORC, THERE WAS POSSIBILITY THAT THE REPORTED EVENT WAS ATTRIBUTED TO THE STRESS DURING USE, THE EXTERNAL FACTOR AND/OR THE USER HANDLING. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT IT WAS FOUND THAT THE COATING OF THE INSERTION TUBE OF THE SUBJECT DEVICE HAD BEEN PARTIALLY PEELED OFF. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835750 TRACHEAL INTUBATION FIBERSCOPE TRACHEAL INTUBATION FIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. LF-DP

    Patients

    Seq Age Sex Outcome Treatment
    1