BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE

    MDR report key: 17066594 · Received June 5, 2023

    Report

    Report Number
    9610773-2023-01551
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    April 19, 2023
    Report Date
    September 13, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    EWY
    UDI-DI
    04042761052764
    PMA / PMN Number
    K950076
    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. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE CONCLUSIVELY 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.

    Additional Manufacturer Narrative · 0

    OLYMPUS FOLLOWED UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT, BUT NO FURTHER INFORMATION WAS OBTAINED OR PROVIDED BY THE CUSTOMER. THE REFERENCED DEVICE WAS RETURNED FOR EVALUATION AND THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. THE EVALUATION ALSO NOTED THE FOLLOWING NON-REPORTABLE DEFECTS: THE OUTER TUBE IS DENTED, AND THE LIGHT GUIDE CONNECTOR IS BENT. A REVIEW OF THE (DHR) MANUFACTURING AND QUALITY RECORDS FOR THE AFFECTED SERIAL NUMBER WAS REVIEWED WITHOUT DETECTING 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): K912362/ K923982.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING REPROCESSING THE HIGH-DEFINITION QUICK LOCK RIGID TELESCOPE WAS FOUND TO HAVE A CRACKED EYEPIECE JOINT. IT WAS REPORTED THE PROCEDURE WAS COMPLETED. 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
    530500 TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE RIGID SCOPE EWY OLYMPUS WINTER & IBE GMBH WA53005A 624819 04042761052764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OLYMPUS: CH-S190-XZ-E, CAMERA HEAD