BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16989806 · Received May 23, 2023

    Report

    Report Number
    9610773-2023-01415
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    April 19, 2023
    Report Date
    July 24, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HRX
    UDI-DI
    04042761010542
    PMA / PMN Number
    K950076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 AS THE DEVICE WAS NOT RETURNED. HOWEVER, BASED ON THE ERROR PATTERN, IT IS LIKELY THE REPORTED EVENT OCCURRED DUE TO EXCESSIVE USE.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE AFFECTED SERIAL NUMBER WAS REVIEWED WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. THE INVESTIGATION IS STILL IN PROGRESS; HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE END-USER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. ADDITIONAL 510(K): K951354 / K944072.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING REPROCESSING THE TRUEVIEW II, AUTOCLAVABLE TELESCOPE WAS FOUND TO HAVE A BROKEN COMPONENT, ¿PRISM BROKEN¿. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515876 TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE RIGID SCOPE HRX OLYMPUS WINTER & IBE GMBH A70941A 803395 04042761010542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown