BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE "TRUEVIEW II", 4 MM, 0°, AUTOCLAVABLE

    MDR report key: 16377210 · Received February 15, 2023

    Report

    Report Number
    9610773-2023-00504
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    January 13, 2023
    Report Date
    May 20, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HRX
    UDI-DI
    04042761010535
    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 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 OF THE CRACKED LENS WAS DUE TO USER ERROR, IMPROPER HANDLING, APPLICATION OF EXCESSIVE FORCE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE REFERENCED SCOPE WAS RETURNED TO THE OLYMPUS REPAIR CENTER. THE REPAIR INSPECTION CONFIRMED THE CUSTOMER¿S REPORTED ISSUE, THE OBJECTIVE LENS IS DAMAGED. ALSO THE INSPECTION NOTED THE SCOPE IS DAMAGED INSIDE THE COVERGLASS. THE INVESTIGATION IS STILL ONGOING; 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.

    Description of Event or Problem · 0

    OLYMPUS (OMCS) WAS INFORMED THAT THE CUSTOMER TRUEVIEW II AUTOCLAVABLE TELESCOPE HAS A CRACKED LENS. THE CUSTOMER REPORTED EVENT WAS FOUND AT PRE-USE INSPECTION. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER WAS REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204760 TELESCOPE "TRUEVIEW II", 4 MM, 0°, AUTOCLAVABLE AUTOCLAVABLE TELESCOPE HRX OLYMPUS WINTER & IBE GMBH A70940A 696129 04042761010535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown