BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE

    MDR report key: 16432327 · Received February 23, 2023

    Report

    Report Number
    9610773-2023-00568
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Report Date
    May 10, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    EWY
    UDI-DI
    04042761052757
    PMA / PMN Number
    K912362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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 EVENTS, BROKEN EYEPIECE AND BROKEN LIGHT GUIDE COVER GLASS, OCCURRED DUE TO THE USE OF EXCESSIVE FORCE BY THE CUSTOMER. IN ADDITION, THE FOLLOWING NON-REPORTABLE MALFUNCTION WAS FOUND DURING THE DEVICE EVALUATION: DENTS ON THE OUTER TUBE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. DURING THEIR INSPECTION, IT WAS FOUND THAT THE EYEPIECE WAS BROKEN AND THE LIGHT GUIDE (LG) COVER GLASS WAS BROKEN. 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. ADDITIONAL PMA/510(K) NUMBER: K923982/ K950076. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE WAS SENT IN FOR REPAIR. INCOMING INSPECTION FOUND THE EYEPIECE BROKEN AND LIGHT GUIDE (LG) COVER GLASS WAS BROKEN. THE REPORTED ISSUE WAS FOUND DURING ESTIMATION OF THE DEVICE. THERE WAS NO INJURY OR HEALTH DAMAGE DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473447 TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE MEDIASTINOSCOPE EWY OLYMPUS WINTER & IBE GMBH WA53000A 556985 04042761052757

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown