BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLE-26-012

    MDR report key: 381561 · Received March 11, 2002

    Report

    Report Number
    MW1024343
    Event Type
    Malfunction
    Date Received
    March 11, 2002
    Date of Event
    March 6, 2002
    Report Date
    March 11, 2002
    Manufacturer
    CIRCON CORP
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING TRANSURETHRAL RESECTION THE LOOP BROKE OFF IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MLE-26-012 RIGHT ANGLE CUTTING LOOP ELECTRODE FAS CIRCON CORP * JE5536

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR