BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16637215 · Received March 29, 2023

    Report

    Report Number
    9610773-2023-00902
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    February 27, 2023
    Report Date
    July 11, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION, DEVICE EVALUATION, AND CORRECTION TO G2 (ALSO SELECTED ¿OTHER¿ WHICH WAS INADVERTENTLY LEFT OFF THE INITIAL REPORT). THE CUSTOMERS COMPLAINT WAS CONFIRMED. ADDITIONAL NON REPORTABLE DEFECTS WERE FOUND DURING DEVICE EVALUATION: INSERTION TUBE WAS DENTED AND CONTAMINATION WAS EVIDENT INSIDE THE EYEPIECE. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE EVENT OCCURRED DUE TO USE OF EXCESSIVE FORCE BY THE CUSTOMER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. 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 AN EYEPIECE DETACHED FROM THE BODY OF THE DEVICE. THERE WAS NO PROCEDURE INVOLVED. THE DEVICE WAS LOCKED IN A CUPBOARD, NOT USED FOR A LONG TIME, WHEN THEY OPENED IT WAS SQUASHED AGAINST INTERNAL WALL AND EYE PIECE CAME OFF WHEN TOOK OUT. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775950 TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE MEDIASTINOSCOPE EWY OLYMPUS WINTER & IBE GMBH WA53005A UNKNOWN 04042761052764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown