BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE

    MDR report key: 16877442 · Received May 5, 2023

    Report

    Report Number
    3003724334-2023-00008
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Report Date
    June 27, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH¿
    Product Code
    HRX
    UDI-DI
    04042761010559
    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 THE CUSTOMER'S ALLEGATION WAS ABLE TO BE CONFIRMED. DURING THE DEVICE EVALUATION IT WAS OBSERVED THAT THERE WAS A CLOUDY IMAGE AND POOR ILLUMINATION DUE TO A BROKEN LIGHT GUIDE. ADDITIONALLY, IT WAS OBSERVED THAT THE INTERNAL LENS WAS DAMAGED. UPON FURTHER INSPECTION IT WAS OBSERVED THAT THERE WERE SCRATCHES ON THE TIP COVER GLASS. LASTLY, IT WAS OBSERVED THAT THERE WAS PEELING OF THE GOLD PLATING ON THE OUTER TUBE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. ADDITIONAL FDA 510(K)/ PMA: K944072 AND K950076.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE LENS HAD CLOUDINESS. THE REPORTED ISSUE WAS DISCOVERED DURING DEVICE INSPECTION. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468405 TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE ARTHROSCOPE HRX OLYMPUS WINTER & IBE GMBH¿ HW70942 569063 04042761010559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ESG-400, CABLE.