BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 10 MM, 45°, HD, QUICK LOCK, AUTOCLAVABLE

    MDR report key: 16563059 · Received March 17, 2023

    Report

    Report Number
    9610773-2023-00777
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Report Date
    July 5, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    EWY
    UDI-DI
    04042761052771
    PMA / PMN Number
    K912362
    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 AND CORRECTION TO H8. PLEASE SEE UPDATES TO H6, H8, AND H10. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 12 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT¿S LIKELY THE CONNECTOR PART COULDN¿T BE REMOVED DUE TO USER ERROR, IMPROPER HANDLING AND APPLICATION OF EXCESSIVE FORCE. THE FINAL ROOT CAUSE OF THIS EVENT WAS UNABLE TO BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO THE OLYMPUS REPAIR CENTER FOR EVALUATION AND THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED/REPRODUCED AS THE LIGHT GUIDE POST WAS DAMAGED. ADDITIONALLY, THE OBJECTIVE COVERGLASS AT THE DISTAL END OF THE SCOPE WAS FOUND BROKEN. THE INSPECTION ALSO OBSERVED A DENT ON THE RIGID OUTER TUBE AND THE IMAGE IS BLURRY OR DISTORTED. 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 501(K): K923982/ K950076.

    Description of Event or Problem · 0

    THE CUSTOMER HIGH DEFINITION, QUICK LOCK AUTOCLAVABLE RIGID TELESCOPE WAS RETURNED TO THE OLYMPUS REPAIR CENTER FOR A REPORTED ¿THE LIGHT GUIDE CONNECTOR PART CANNOT BE REMOVED¿. THE CUSTOMER REPORTED EVENT WAS FOUND AT AN UNSPECIFIED EVENT. DURING THE OLYMPUS INSPECTION, A BROKEN OBJECTIVE COVERGLASS AT THE DISTAL END OF THE SCOPE WAS FOUND. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS. NO FURTHER DETAILS REGARDING THE EVENT HAVE BEEN OBTAINED OR PROVIDED. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE BROKEN OBJECTIVE LENS AT THE DISTAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547866 TELESCOPE, 10 MM, 45°, HD, QUICK LOCK, AUTOCLAVABLE AUTOCLAVABLE RIGID TELESCOPE EWY OLYMPUS WINTER & IBE GMBH WA53010A 588602 04042761052771

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown