BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16940444 · Received May 16, 2023

    Report

    Report Number
    9610773-2023-01327
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    April 11, 2023
    Report Date
    July 21, 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

    G4-ADDITIONAL 510(K) NUMBERS: K923982 AND K950076. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION, THEREFORE THE DEVICE EVALUATION COULD NOT BE COMPLETED AT THIS TIME. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL 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 COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION, IT IS LIKELY THE REPORTED EVENT OCCURRED DUE TO THE USE OF EXCESSIVE FORCE BY THE CUSTOMER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING REPROCESSING, THE TELESCOPE WAS FOUND TO NOT BE FUNCTIONAL WITH BROKEN PARTS. THIS FAULT OCCURRED DUE TO CUSTOMER HANDLING DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864034 TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE MEDIASTINOSCOPE, SURGICAL EWY OLYMPUS WINTER & IBE GMBH WA53005A 656350 04042761052764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown