BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH A0396

    MDR report key: 6180308 · Received December 16, 2016

    Report

    Report Number
    9610773-2016-10008
    Event Type
    Injury
    Date Received
    December 16, 2016
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FGB
    PMA / PMN Number
    PK951855
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEVICE RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE PATIENTS' OUTCOMES AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS BUT MAY BE REOPENED IF A DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME. THEN, THIS REPORT WILL BE UPDATED. FURTHERMORE, THE REPORTED EVENTS/INCIDENTS WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. PLEASE NOTE: THIS REPORT IS BEING SUBMITTED ALTHOUGH THE SUSPECT MEDICAL DEVICE IS NOT MARKETED IN THE USA. HOWEVER, A SIMILAR DEVICE IS MARKETED. MODEL # / CATALOG #: WA29042A; BRAND NAME: URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH WA00396A; COMMON DEVICE NAME: URETEROSCOPES, AUTOCLAVABLE; 510(K): K951855; PRODUCT CODE: FGB.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AFTER UNSPECIFIED ENDOSCOPIC PROCEDURES AT UNKNOWN DATES, SEVEN PATIENTS DEVELOPED A URINARY TRACT INFECTION. NO FURTHER INFORMATION WAS PROVIDED AND THE CAUSE OF THIS COMPLICATION IS UNKNOWN AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832038 URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH A0396 URETEROSCOPES, AUTOCLAVABLE FGB OLYMPUS WINTER & IBE GMBH WA29042B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention