BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USA SERIES ACN-2 FLEXIBLE CYSTONEPHROSCOPE

    MDR report key: 280133 · Received May 30, 2000

    Report

    Report Number
    1218764-2000-00005
    Event Type
    Malfunction
    Date Received
    May 30, 2000
    Date of Event
    May 12, 2000
    Report Date
    May 30, 2000
    Manufacturer
    CIRCON ACMI
    Product Code
    FAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, AS THE PHYSICIAN REMOVED THE SCOPE FROM THE PATIENT'S URETHRA, IT WAS NOTED THAT "A FEW INCHES OF THE PROTECTIVE COATING ON THE FLEXIBLE END HAD FLAKED OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA SERIES ACN-2 FLEXIBLE CYSTONEPHROSCOPE CYSTOSCOPE FAJ CIRCON ACMI ACN-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO