BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

    MDR report key: 1821145 · Received August 9, 2007

    Report

    Report Number
    1527736-2007-05289
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    July 31, 2007
    Report Date
    July 31, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BASED UPON THE INQUIRY INFORMATION RECEIVED VISUAL AND FUNCTIONAL EXAMINATION: THE UNIT WAS FOUND TO REQUIRE THE VACUUM PUMP TO BE REPLACED. THE DEVICE WAS FUNCTIONALLY TESTED, MET ALL PRODUCT REQUIREMENTS AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE AT AN ACCOUNT WHEN IT WAS TURNED ON THERE WAS A LOUD KNOCKING NOISE COMING FROM THE UNIT INTERNALLY. HE SHUT THE UNIT DOWN AND REBOOTED AND CONTINUED TO HEAR THE NOISE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE| HOLSTER