BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 20102252 · Received August 29, 2024

    Report

    Report Number
    9610595-2024-17371
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 30, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FGB
    PMA / PMN Number
    K181451
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS 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 2429304-2024-0000396.

    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. IT HAS BEEN LESS THAN 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, AFTER THE STONES WERE LODGED, THE DOCTOR APPLIED STEADY PRESSURE TO REMOVE THE SCOPE, WHICH CAUSED THE DROPPING OF THE SHEATH. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. MOREOVER, THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION; HOWEVER, A PHOTO OF THE DEVICE WAS PROVIDED AND IT WAS NOTED THAT BENDING TUBE AND INTERNAL ELEMENTS OF THE DEVICE WERE EXPOSED. ALSO, PART OF THE DISTAL END AND BENDING TUBE WERE MISSING. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE IFU IN SECTION: "OPERATION MANUAL: 3.3 INSPECTION OF THE ENDOSCOPE". "4.1 PRECAUTIONS: WARNING: IF SIGNIFICANT RESISTANCE IS FELT DURING INSERTION DUE TO AN ANATOMICAL REASON, DO NOT INSERT OR WITHDRAW THE ENDOSCOPE WITH EXCESSIVE FORCE. OTHERWISE, URETER INJURY, BLEEDING, AND/OR PERFORATION MAY OCCUR." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT WAS INJURED DURING A THERAPEUTIC CYSTOSCOPY PROCEDURE USING THE URETERO-RENO FIBERSCOPE. THE TIP OF THE SCOPE BROKE OFF DURING THE PROCEDURE. THERE WERE SEVERAL SHARP KIDNEY STONES PRESENT. THE DOCTOR WAS REMOVING THE KIDNEY STONES WHEN THE STONES LODGED, CREATING A LIP. THE DOCTOR COULD NOT MOVE THE SCOPE FORWARD OR BACKWARD. THE DOCTOR USED STEADY PRESSURE TO REMOVE THE SCOPE. THE STEADY PRESSURE CAUSED DEGLOVING OF THE SHEATH. THE DOCTOR HAD TO OPEN THE PATIENT WITH AN INCISION ON THE LOWER ABDOMEN TO REMOVE THE FOREIGN BODY. WHEN THE SCOPE WAS REMOVED FROM THE PATIENT, WIRES WERE EXPOSED AND THE SHEATH WAS MISSING. FURTHER INFORMATION REGARDING PATIENT IMPACT WAS REQUESTED, BUT NOT PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314355 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB AIZU OLYMPUS CO., LTD. URF-P7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention