BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16747037 · Received April 14, 2023

    Report

    Report Number
    9610773-2023-01047
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Report Date
    July 24, 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

    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): K944072 / K950076.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTION TO G2, ADDING OTHER AND JAPAN. INFORMATION WAS INADVERTENTLY NOT INCLUDED ON THE INITIAL MEDWATCH. THE DEVICE WAS RETURNED AND AN EVALUATION WAS COMPLETED FOR IT. DURING INSPECTION, OLYMPUS CONFIRMED THE REPORTED EVENT, THE COVER GLASS WAS DAMAGED. ADDITIONALLY, THERE WAS BENDING ON THE OUTER TUBE, POOR LIGHTING DUE TO A BROKEN LIGHT GUIDE, IMAGE FAILURE DUE TO LENS DAMAGE, AND PEELING OF THE GOLD PLATING ON THE OUTER TUBE; HOWEVER, THESE DEFECTS ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 11 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE DAMAGE TO THE COVER GLASS OF THE OUT TUBE OCCURRED DUE TO USER ERROR, IMPROPER HANDLING AND WEAR AND TEAR. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE "TRUEVIEW II" WAS SENT IN FOR REPAIR. THE LENS AND THE FIELD OF VIEW WERE CRACKED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319521 TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE ARTHROSCOPE HRX OLYMPUS WINTER & IBE GMBH A70941A 618345 04042761010542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown