BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMM MR 8G BLADELESS PROBE SET

    MDR report key: 1788336 · Received August 7, 2010

    Report

    Report Number
    3005075853-2010-04500
    Event Type
    Malfunction
    Date Received
    August 7, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    EXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROBE WAS GETTING INTERMITTENT SAMPLES AND GIVING ERROR CODES DURING AN MR ASSISTED BREAST BIOPSY. THE CUSTOMER ALSO NOTICED THE CLEAR PROBE MODE WOULDN'T FUNCTION CORRECTLY. THE PROBE WAS REMOVED FROM THE PATIENT'S BREAST AND IT WAS NOTICED THERE WERE A LOT OF SAMPLES JAMMED INTO THE END OF THE NEEDLE. THE SAMPLES WERE REMOVED FROM THE PROBE AND THE CUSTOMER DISCARDED THE PROBE BEFORE THE DEVICE COULD BE SAVED FOR RETURN FOR ANALYSIS. THE CASE WAS COMPLETED USING A SECOND PROBE WITH NO CONSEQUENCE TO THE PATIENT. PATIENT INFORMATION WAS REQUESTED BUT LITTLE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMM MR 8G BLADELESS PROBE SET EXX ETHICON ENDO-SURGERY, LLC. NA F4PC0X

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE, HOLSTER