BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 8643418 · Received May 27, 2019

    Report

    Report Number
    8010047-2019-02024
    Event Type
    Malfunction
    Date Received
    May 27, 2019
    Date of Event
    April 30, 2019
    Report Date
    June 3, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K172298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION AND CORRECT THE SECTION G4 ¿DATE RECEIVED BY MANUFACTURER¿. ON APRIL 25TH, 2019, OLYMPUS RECEIVED THE FOLLOWING INFORMATION FROM THE USER FACILITY. BLACK DOTS WERE DISPLAYED ON THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE DURING A RETROGRADE INTRARENAL SURGERY. THE DOCTOR HAD TO REMOVE THE SUBJECT DEVICE FROM THE PATIENT DURING THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THEREFORE, THE REC¿D BY MFR "DATE RECEIVED BY MANUFACTURER" HAS BEEN CHANGED TO (B)(6) 2019 FROM (B)(6) 2019.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS INDIA PRIVATE LIMITED (OMSI). OMSI EVALUATED THE SUBJECT DEVICE AND CONFIRMED AS FOLLOWS; THERE WAS AN AIR LEAK FROM THE BENDING SECTION RUBBER AT THE POSITION WHERE THE BENDING SECTION WAS BROKEN. THERE WAS NO MAJOR DENT IN THE INSERTION TUBE OR THE DISTAL END. THERE WAS NO REMARKABLE DENT OR THE HITTING DENT ON THE SUBJECT DEVICE. THE LAST REPAIR WAS CARRIED OUT FOR THE DEVICE ON MARCH 11TH, 2019. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A RETROGRADE INTRARENAL SURGERY, THE USER FACILITY NOTICED THAT BLACK DOTS WERE DISPLAYED ON THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE, AND IT WAS NECESSARY TO REPLACE THE DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437709 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P6R

    Patients

    Seq Age Sex Outcome Treatment
    1