BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE

    MDR report key: 16381802 · Received February 15, 2023

    Report

    Report Number
    9610773-2023-00507
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Report Date
    May 4, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    EWY
    UDI-DI
    04042761052764
    PMA / PMN Number
    K912362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PMA/510(K) NUMBERS K923982/ K950076. THE DEVICE WAS RETURNED TO OLYMPUS. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. IT IS LIKELY THE REPORTED EVENT OCCURRED DUE TO THE USE OF EXCESSIVE FORCE BY THE CUSTOMER. IN ADDITION, THE FOLLOWING NON-REPORTABLE MALFUNCTIONS WERE FOUND DURING THE DEVICE EVALUATION; THE LIGHT GUIDE WAS DEEPLY SCRATCHED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT THE EYEPIECE WAS DAMAGED ON A TELESCOPE. THE REPORTED ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WAS NO INJURY OR HEALTH DAMAGE DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205043 TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE MEDIASTINOSCOPE EWY OLYMPUS WINTER & IBE GMBH WA53005A 779890 04042761052764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown