BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEROSCOPE 6.9/8.4 FR. X 430 MM, 5°, STRAIGHT OCULAR, 3.7 FR. 2.6 FR. CHANNEL

    MDR report key: 20845564 · Received December 4, 2024

    Report

    Report Number
    9610773-2024-02735
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    September 17, 2024
    Report Date
    February 25, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FGB
    UDI-DI
    04042761086431
    PMA / PMN Number
    K200369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G3 REFLECTS THE DATE OLYMPUS BECAME AWARE OF A REPORTABLE MALFUNCTION. ON NOVEMBER 14, 2024, OLYMPUS BECAME AWARE OF A SERIOUS INJURY THOUGH ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000475. THIS REPORT HAS BEEN SUBMITTED BY THE USER FACILITY UNDER THIS MDR REPORT NUMBER MW5160436.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S (LM) INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN ABOUT 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR A PHYSICAL EVALUATION. HOWEVER, BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED FAILURE WAS LIKELY DUE TO EXCESSIVE FORCE. THIS MAY HAVE BEEN CAUSED BY A LARGE MECHANICAL FORCE DUE TO A SHOCK, FALL OR COLLISION WITH OTHER EQUIPMENT. THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO D8. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A SEMI-RIGID URETEROSCOPE DURING A CYSTOSCOPY, THE END BROKE OFF WHILE INSIDE THE PATIENT'S URETHRA. THE END DETACHED AND FELL INSIDE THE URETHRA, BUT IT CAME OUT WHEN THE SCOPE WAS REMOVED. THE URETHRA WAS VISUALIZED USING A SECOND SCOPE AND THERE WERE NO SIGNS OF INJURY. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871418 URETEROSCOPE 6.9/8.4 FR. X 430 MM, 5°, STRAIGHT OCULAR, 3.7 FR. 2.6 FR. CHANNEL URETEROSCOPE FGB OLYMPUS WINTER & IBE GMBH WA2UR23A 04042761086431

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention