BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16832043 · Received April 28, 2023

    Report

    Report Number
    9610773-2023-01166
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Report Date
    July 27, 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

    B5 (INFORMATION WAS INADVERTENTLY OMITTED), D5, G2 (ADDED SELECTION), H8 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 EVENT OCCURRED DUE TO THE USE OF EXCESSIVE FORCE FROM IMPROPER HANDLING IN COMBINATION WITH WEAR AND TEAR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE LIGHT GUIDE CABLE CONNECTOR HAS BECOME LOOSE AND THE GOLD PLATING ON THE OUTER TUBE HAS WORN OFF. THIS REPORT IS BEING SUBMITTED FOR THE DEFECTIVE LIGHT GUIDE CONNECTOR. IT WAS ALSO NOTED THAT THE DEVICE WAS INSPECTED BEFORE USE AND THAT THE INTENDED PROCEDURE WAS COMPLETED WITHOUT DELAY USING A DIFFERENT SCOPE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE WAS SENT IN FOR EVALUATION AND REPAIR FOR A BROKEN TIP. DURING THE EVALUATION, OLYMPUS STAFF DISCOVERED REPORTABLE MALFUNCTIONS. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045866 TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE RIGID SCOPE EWY OLYMPUS WINTER & IBE GMBH WA53000A 669060 04042761052757

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown