BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 20/240V

    MDR report key: 1830331 · Received August 10, 2007

    Report

    Report Number
    1527736-2007-05317
    Event Type
    Malfunction
    Date Received
    August 10, 2007
    Date of Event
    June 20, 2007
    Report Date
    June 21, 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 UPON THE INQUIRY INFO RECEIVED VISUAL AND FUNCTIONAL EXAMINATION: THE UNIT WAS FOUND TO REQUIRE THE DC MOTOR ADAPTOR AND UNIBOARD 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 THEY ARE RETURNED THEIR UNIT FOR SERVICE. DESCRIPTION OF FAILURE: FIRST ERROR CODE L3-017 AND THEN ERROR CODE L3-002. NO FURTHER INFO IS AVAILABLE. NO REPORTED PATIENT 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) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| PROBE