BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO VIDEOSCOPE

    MDR report key: 9420701 · Received December 5, 2019

    Report

    Report Number
    8010047-2019-04179
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Report Date
    January 16, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K072957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO ADDITIONAL INFORMATION. OMSC COULD NOT DETERMINE THE EXACT CAUSE OF THIS PHENOMENON. HOWEVER, BASED UPON THE INFORMATION FROM OLYMPUS GERMANY REPAIR CENTER, THIS PHENOMENON MAY HAVE OCCURRED DUE TO A PHYSICAL DAMAGE FROM EXTERNAL SHOCK.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE EVALUATION RESULT OF THE DEVICE. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. 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 THE INTERNAL METAL PART WAS EXPOSED FROM THE BENDING SECTION OF SUBJECT DEVICE DURING AN INCOMING INSPECTION AT OLYMPUS (B)(4) REPAIR SERVICE CENTER. IN THE INCOMING INSPECTION, OLYMPUS (B)(4) REPAIR SERVICE CENTER FOUND THAT THE SUBJECT DEVICE FAILED THE LEAKAGE TEST, THE UP ANGLE WIRE WAS DAMAGED AND THE INSIDE OF THE CONTROL SECTION WAS CORRODED. OTHER DETAILED INFORMATION SUCH AS WHEN THE EVENT OCCURRED WAS NOT PROVIDED FROM THE USER FACILITY. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214076 URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-V

    Patients

    Seq Age Sex Outcome Treatment
    1