BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACMI

    MDR report key: 1013095 · Received March 11, 2008

    Report

    Report Number
    MW5005866
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ACMI
    Product Code
    FAJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A CYSTOSCOPIC TURP PROCEDURE THE TECH NOTICED THE PORCELAIN TIP MISSING FROM THE SCOPE WHICH APPARENTLY FRACTURED OFF WHILE IN THE PT. THE TIP WAS DISCOVERED IN THE BLADDER AND REMOVED. NO APPARENT INJURY TO THE URETHRA WHEN CHECKED, NO FRAGMENTS WERE MISSING. THE INSTRUMENT WAS CHECKED FOR DEFICIENCIES BEFORE USE WITH NO FRACTURES NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACMI SCOPE FAJ ACMI EIS-HCF25

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening