BEUDAMED
    FDA Adverse Event Summary report: N

    RESECTOSCOPE

    MDR report key: 1344490 · Received March 6, 2009

    Report

    Report Number
    1344490
    Date Received
    March 6, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 6, 2009
    Manufacturer
    GYRUS ACMI
    Product Code
    FJL
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CYSTO PROCEDURE, A SMALL PIECE OF PLASTIC 2X2 MM ACROSS BROKE OFF FROM THE RESECTOSCOPE END INTO THE PATIENT'S BLADDER. BLADDER IRRIGATED, BUT NOTHING FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESECTOSCOPE RESECTOSCOPE FJL GYRUS ACMI EMRS 24B *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR