BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 20/240V

    MDR report key: 1821144 · Received August 9, 2007

    Report

    Report Number
    1527736-2007-05288
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Report Date
    July 27, 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
    IT
    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 THAT PRIOR TO AN UNKNOWN PROCEDURE, THERE WAS A PROBLEM WITH THE VACUUM. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME CONTROL MODULE WITH SMARTVAC - 20/240V KNW ETHICON ENDO SURGERY, INC (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| PROBE