BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17399660 · Received July 26, 2023

    Report

    Report Number
    9610773-2023-02013
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Report Date
    January 16, 2024
    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. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. 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 REPORTED EVENT IS UNABLE TO BE DETERMINED. HOWEVER, THE CAUSE OF THE EVENT IS LIKELY DUE TO WEAR AND TEAR AND INSUFFICIENT OR INADEQUATE REPROCESSING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS REPAIR CENTER FOR EVALUATION AND THE CUSTOMER¿S REPORTED ISSUE WAS CONFIRMED. THE DEVICE EVALUATION FOUND THAT A BENT LIGHT SOURCE CORD CONNECTION, BROKEN EYEPIECE RING AND SCRATCHES ON TIP COVER GLASS. IN ADDITION, THE DEVALUATION ALSO FOUND THE OUTER TUBE WAS BENT, THERE WERE DEPOSITS ON THE COVER GLASS AND CORROSION ON THE EYE PIECE RINGS. THERE WAS FOREIGN MATERIAL ADHESION FOUND ON THE INTERNAL LENS AND STICKING OF THE EYE PIECE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE SCOPE HAD BROKEN AND REQUESTED IT BE REPAIRED. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE FOUND: BENT LIGHT SOURCE CORD CONNECTION, BROKEN EYEPIECE RING AND SCRATCHES ON TIP COVER GLASS. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840660 TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE ARTHROSCOPES HRX OLYMPUS WINTER & IBE GMBH A70941A 501689 04042761010542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown