BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO VIDEOSCOPE

    MDR report key: 6716201 · Received July 14, 2017

    Report

    Report Number
    2951238-2017-00460
    Event Type
    Malfunction
    Date Received
    July 14, 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
    CA, 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. A VISUAL INSPECTION OF THE SCOPE NOTED A PUNCTURE OF THE BENDING SECTION COVER ON THE INSERTION TUBE SIDE; HOWEVER, NO SHARP OBJECTS WERE FOUND PROTRUDING THROUGH THE PUNCTURE/HOLE WHEN INSPECTED. FURTHER INSPECTION OF THE BENDING SECTION FOUND THE BENDING SECTION MESH BROKEN AND LIFTING, WHEN THE BENDING SECTION COVER WAS REMOVED. BASED ON THE EVALUATION RESULTS AND SIMILAR REPORTED EVENTS, THE CAUSE OF THE DAMAGE BENDING SECTION METAL RIBS IS LIKELY ATTRIBUTED TO USER HANDLING AND/OR EXCESSIVE FORCE. THE INSTRUCTION MANUAL FOR USE PROVIDES WARNING AND CAUTION STATEMENTS IN AN EFFORT TO PREVENT BENDING SECTION 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 UNSPECIFIED PROCEDURE, THE IMAGE WAS DISTORTED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495029 URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-V N/A

    Patients

    Seq Age Sex Outcome Treatment
    1