BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

    MDR report key: 2911596 · Received March 21, 2007

    Report

    Report Number
    1527736-2007-01855
    Event Type
    Malfunction
    Date Received
    March 21, 2007
    Date of Event
    February 15, 2007
    Report Date
    February 23, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE CONTROL MODULE IS NOT GIVING ADEQUATE SUCTION. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CASE WAS COMPLETED USING THE CONTROL MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V KNW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| PROBE