BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE

    MDR report key: 17007717 · Received May 25, 2023

    Report

    Report Number
    9610773-2023-01437
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Report Date
    September 13, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HRX
    UDI-DI
    04042761010542
    PMA / PMN Number
    K951354
    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 FINAL INVESTIGATION. 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. 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 THE ESTIMATION, PEELING WAS FOUND OF THE GOLD PLATING ON THE OUTER TUBE. THE LIGHT GUIDE WAS BROKEN, AND SCRATCHES WERE OBSERVED ON THE SURFACE OF THE TIP COVER GLASS, IN ADDITION, FOREIGN MATTER ADHESION ON THE INTERNAL LENS. 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. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K944072/ K950076.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS BY A TELESCOPE HAD A BROKEN INSERTION TIP (MELTING). THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS. THE REPORTABLE EVENT WAS FOUND WHEN THE DEVICE WAS EVALUATED DURING INITIAL ESTIMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649856 TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE RIGID SCOPE HRX OLYMPUS WINTER & IBE GMBH A70941A 518363 04042761010542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown