BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16499946 · Received March 7, 2023

    Report

    Report Number
    9610773-2023-00680
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 6, 2023
    Report Date
    April 21, 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
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. 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 PMA/510(K): K923982/ K950076.

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH IS BEING SUPPLEMENTED WITH ADDITIONAL INFORMATION OBTAINED AND THE MANUFACTURER'S FINAL INVESTIGATION RESULTS. DURING THEIR INSPECTION, THE RESULT OF OUR INVESTIGATION WAS CONSISTENT WITH THE CUSTOMER'S DESCRIPTION OF FAILURE. THE IMAGE WAS BLURRY DUE TO BROKEN LENSES IN THE OPTICAL SYSTEM. THE MENISCUS WAS DETACHED (BROKEN BONDING). THIS DAMAGE CAN ONLY OCCUR DUE TO EXTERNAL FORCE BY THE USER. IT IS LIKELY THAT THE INNER DAMAGE IS CAUSED BY THE OUTER DAMAGE. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE WAS RETURNED FOR REPAIR DUE TO A BLURRY IMAGE AND A BROKEN LENS. IT IS UNKNOWN WHEN THE REPORTED ISSUE WAS FOUND. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790975 TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE MEDIASTINOSCOPE EWY OLYMPUS WINTER & IBE GMBH WA53005A 805396 04042761052764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown