BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACMI (MLE-24-012)

    MDR report key: 752515 · Received May 13, 2005

    Report

    Report Number
    MW1035583
    Event Type
    Other
    Date Received
    May 13, 2005
    Date of Event
    May 3, 2005
    Report Date
    May 6, 2005
    Manufacturer
    ACMI
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING AN ELECTRODE FOR A CYSTO TURP. DURING THE RESECTION HE SAW A FLASH OF BRIGHT WHITE LIGHT. HE PULLED OUT THE ELECTRODE AND THE TIP WAS BROKEN. THE ELECTRODE WAS REPLACED WITH A NEW ONE. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACMI (MLE-24-012) ELECTRODE KNS ACMI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other