BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16411152 · Received February 21, 2023

    Report

    Report Number
    9610773-2023-00541
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    December 13, 2022
    Report Date
    May 9, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    EWY
    UDI-DI
    04042761052764
    PMA / PMN Number
    K912362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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 AND TO CORRECT G2. 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 COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. ALTHOUGH THE DEVICE WAS NOT RETURNED, BASED ON THE INFORMATION PROVIDED FROM THE CUSTOMER, IT IS LIKELY THE BAD IMAGE OCCURRED TO A DAMAGED OPTICAL SYSTEM. THE DAMAGE TO THE OPTICAL SYSTEM AND BLACK OPTIC SLEEVE/EYE PIECE FUNNEL WERE CAUSED BY EXCESSIVE FORCE FROM THE FALL IMPACT DUE TO IMPROPER HANDLING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PMA/510K NUMBERS K923982/K950076. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE FELL ON THE GROUND DURING REPROCESSING. THERE WAS A MECHANICAL FAILURE THAT LED TO BAD IMAGE AND A CRACKED OPTIC SLEEVE. THERE WAS NO INJURY OR HEALTH DAMAGE DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644237 TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE MEDIASTINOSCOPE EWY OLYMPUS WINTER & IBE GMBH WA53005A 714497 04042761052764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown