BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16588893 · Received March 22, 2023

    Report

    Report Number
    9610773-2023-00837
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Report Date
    July 13, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S 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 OF THE BROKEN LIGHT GUILD CONNECTION CAN BE ATTRIBUTED TO USER ERROR, IMPROPER HANDLING AND APPLICATION OF EXCESSIVE FORCE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO THE OLYMPUS FOR EVALUATION AND THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED, THE LIGHT GUIDE POST WAS DETACHED FROM THE SCOPE. THE INVESTIGATION IS STILL IN PROGRESS; HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE END-USER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. ADDITIONAL 501(K): K923982/K950076.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE QUICK LOCK, HIGH DEFINITION AUTOCLAVABLE TELESCOPE HAS A BROKEN COMPONENT DEFECT, ¿DETACHMENT OF LIGHT GUIDE CONNECTION THE CUSTOMER REPORTED PROBLEM OCCURRED WHEN WASHING THE TELESCOPE AS THE LIGHT GUIDE CONNECTION WAS TURNED WITH FORCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955881 TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE HIGH DEFINITION AUTOCLAVABLE TELESCOPE EWY OLYMPUS WINTER & IBE GMBH WA53000A 728284 04042761052757

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown