BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 20/240V

    MDR report key: 1820936 · Received October 29, 2007

    Report

    Report Number
    1527736-2007-07120
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    August 17, 2007
    Report Date
    August 20, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE AN MDR MALFUNCTION. THE ANALYSIS SITE PERFORMED UPGRADES AND REPLACED THE VSO. AFTER SERVICING THE UNIT PASSED ALL QA FUNCTIONAL TESTING. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS BEING RETURNED TO THE INTERNATIONAL SERVICE CENTER FOR SERVICE. NO FURTHER INFO IS AVAILABLE. NO REPORTED PT CONSEQUENCE.

    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