BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USA SERIES ACN-2 FLEXIBLE CYSTONEPHROSCOPE

    MDR report key: 321825 · Received March 15, 2001

    Report

    Report Number
    1218764-2001-00003
    Event Type
    Malfunction
    Date Received
    March 15, 2001
    Report Date
    March 15, 2001
    Manufacturer
    CIRCON ACMI
    Product Code
    FAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, A SMALL PIECE OF THE MATERIAL COVERING THE SCOPE SHAFT BROKE OFF IN THE PT. THE PIECE WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11710 USA SERIES ACN-2 FLEXIBLE CYSTONEPHROSCOPE 500 FAJ CIRCON ACMI ACN-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO