BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17775380 · Received September 19, 2023

    Report

    Report Number
    3003724334-2023-00038
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Report Date
    July 1, 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
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS ABLE TO BE CONFIRMED. DURING THE DEVICE EVALUATION IT WAS OBSERVED THAT THE LIGHT GUIDE CONNECTOR DISLODGED AND WAS STUCK INSIDE OF THE LIGHT GUIDE CABLE. IT WAS ALSO OBSERVED THAT THERE WAS LIGHT GUIDE BREAKAGE. LASTLY, IT WAS OBSERVED THAT THERE WERE DENTS ON THE OUTER TUBE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. ADDITIONAL PMA/510(K) NUMBERS: K923982/ K950076.

    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 OF THE EVENT WAS UNABLE TO BE IDENTIFIED. THE EVENT LIKELY OCCURRED DUE TO USER ERROR, IMPROPER HANDLING AS WELL AS APPLICATION OF EXCESSIVE FORCE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 9610773.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE HAD AN ADAPTOR DISLODGED AND GOT STUCK IN THE LIGHT CABLE. THE REPORTED ISSUE WAS DISCOVERED AT THE USER FACILITY DURING MAINTENANCE OF THE SCOPE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584605 TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE RIGID OPTICAL LAPAROSCOPE EWY OLYMPUS WINTER & IBE GMBH¿ WA53005A 617246 04042761052764

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown