BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16547976 · Received March 15, 2023

    Report

    Report Number
    9610773-2023-00764
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Report Date
    June 20, 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 MAKE A CORRECTION TO G2 (ALSO SELECTED ¿OTHER¿ WHICH WAS INADVERTENTLY LEFT OFF THE INITIAL AND SUPPLEMENTAL REPORTS). OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE CUSTOMER'S COMPLAINT WAS CONFIRMED; THE LIGHT GUIDE CONNECTOR PARTS WERE DISCONNECTED. 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, IT IS LIKELY THAT THE EVENT 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE WAS SENT IN FOR REPAIR DUE TO LIGHT GUIDE CONNECTOR ISSUES. IT IS UNKNOWN WHEN THE REPORTED ISSUE WAS FOUND. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758258 TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE ARTHROSCOPE HRX OLYMPUS WINTER & IBE GMBH A70941A 621566 04042761010542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown