BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO VIDEOSCOPE

    MDR report key: 6695554 · Received July 7, 2017

    Report

    Report Number
    2951238-2017-00440
    Event Type
    Malfunction
    Date Received
    July 7, 2017
    Date of Event
    June 16, 2017
    Report Date
    March 3, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    PK072957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM NWB TO FGB.

    Additional Manufacturer Narrative · 1

    THE SCOPE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE REPORTED DEVICE ISSUE. A VISUAL INSPECTION WAS PERFORMED AND FOUND THE BENDING SECTION SKELETON BROKEN APART AND DETACHED FROM THE INSERTION TUBE SIDE CAUSING SHARP EDGES. IN ADDITION, THE BENDING SECTION COVER WAS FOUND DAMAGED AND CAUSING THE CHARGE-COUPLED DEVICE (CCD) WIRES TO BE EXPOSED. TO ADD, THE SCOPE COULD NOT BE ANGULATED PROPERLY DUE TO THE DAMAGED BENDING SECTION SKELETON. THE SCOPE WAS SERVICED AND RETURNED TO THE USER FACILITY. BASED ON THE EVALUATION RESULTS AND SIMILAR REPORTED EVENTS, THE CAUSE OF THE BENDING SECTION DAMAGE IS LIKELY ATTRIBUTED TO USER HANDLING. THE INSTRUCTION MANUAL FOR USE PROVIDES WARNING AND CAUTION STATEMENTS IN AN EFFORT TO PREVENT SCOPE DAMAGE. ¿DO NOT ATTEMPT TO BEND OR TWIST THE ENDOSCOPE¿S INSERTION SECTION WITH EXCESSIVE FORCE. THE INSERTION SECTION MAY BE DAMAGED. USING AN ENDOSCOPE THAT IS NOT FUNCTIONING PROPERLY MAY COMPROMISE PATIENT OR OPERATOR SAFETY AND MAY RESULT IN MORE SEVERE EQUIPMENT DAMAGE."

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN URETEROSCOPY PROCEDURE, THE SCOPE WAS IN AN ACUTE ANGLE AND BECAME STUCK INSIDE THE PATIENT'S KIDNEY. THE PHYSICIAN WAS ABLE TO LOOSEN THE ANGULATION AND SUCCESSFULLY REMOVE THE SCOPE FROM THE PATIENT; HOWEVER, THE PHYSICIAN WAS UNABLE TO REMOVE THE KIDNEY STONE AND A FOLLOW UP PROCEDURE WILL TAKE PLACE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472772 URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-V2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1