BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRO-6 MICRO OPERATING URETEROSCOPE

    MDR report key: 234324 · Received July 28, 1999

    Report

    Report Number
    1218764-1999-00013
    Event Type
    Malfunction
    Date Received
    July 28, 1999
    Date of Event
    July 23, 1999
    Report Date
    July 28, 1999
    Manufacturer
    CIRCON ACMI
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT DISTAL END OF SCOPE IS "POINTED AND SHARP" AND SCRATCHED PT'S URETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRO-6 MICRO OPERATING URETEROSCOPE URETEROSCOPE FGB CIRCON ACMI MRO-642 S/N 0447

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO