BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELITE CYSTOSCOPE

    MDR report key: 57361 · Received December 20, 1996

    Report

    Report Number
    MW1010449
    Event Type
    Other
    Date Received
    December 20, 1996
    Date of Event
    November 25, 1996
    Manufacturer
    CIRCON/ACMI
    Product Code
    FAJ
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING CYSTOSCOPY PROCEDURE WHAT SEEMED TO BE METAL FLAKER SHOWED UP ON VIDEO SCREEN. BLADDER IRRIGATED AND GLITTER DISAPPEARED ON FINAL INSPECTION WITH VIDEO. PT HAD SIMILAR INCIDENT ON 11/12/96 WITH OTHER EQUIPMENT WHICH WAS RETURNED TO CO FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE CYSTOSCOPE CYSTOSCOPE FAJ CIRCON/ACMI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other