BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17176696 · Received June 21, 2023

    Report

    Report Number
    9610773-2023-01706
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    May 30, 2023
    Report Date
    May 4, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    EWY
    UDI-DI
    04042761052764
    PMA / PMN Number
    K912362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: H3 AND H6. CORRECTED FIELD: H6 - HEALTH EFFECT/IMPACT CODE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER TWO (2) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE ROD LENS CRUSHED OCCURRED DUE TO EXCESSIVE USE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. DURING THE EVALUATION, THE REPORTED ISSUE WAS CONFIRMED, THE OUTER TUBE WAS CRUSHED. SCRATCHES WERE FOUND ON THE OBJECTIVE WINDOW AND BREAKAGE OF THE OPTICAL FIBERS. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K923982/ K950076

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE HAD THE ROD LENS TUBE CRUSHED. THE REPORTED ISSUE WAS FOUND DURING REPROCESSING OF THE DEVICE. THERE WAS NO PATIENT INVOLVED NOR MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062683 TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE RIGID SCOPE EWY OLYMPUS WINTER & IBE GMBH WA53005A 806110 04042761052764

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown