BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USA SERIES MRO-7 INTEGRAL OPERATING URETEROSCOPE

    MDR report key: 323266 · Received March 23, 2001

    Report

    Report Number
    1218764-2001-00006
    Event Type
    Malfunction
    Date Received
    March 23, 2001
    Date of Event
    February 9, 2001
    Report Date
    March 21, 2001
    Manufacturer
    CIRCON ACMI
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, A FLEXIBLE GUIDEWIRE WAS PASSED DOWN THE SCOPE INTO THE URETER. WHEN RETRACTING GUIDEWIRE AT END OF PROCEDURE, THE DISTAL TIP OF THE SCOPE CUT A SMALL PIECE OF THE GUIDEWIRE OFF, WHICH THEN PASSED UP INTO THE KIDNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13164 USA SERIES MRO-7 INTEGRAL OPERATING URETEROSCOPE 500 FGB CIRCON ACMI MRO-742 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO