BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

    MDR report key: 1820889 · Received July 27, 2007

    Report

    Report Number
    1527736-2007-04943
    Event Type
    Malfunction
    Date Received
    July 27, 2007
    Date of Event
    July 16, 2007
    Report Date
    July 17, 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
    TN, 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 VSO VACUUM SYSTEM 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 THE DISPLAY ON THE CONTROL MODULE FLICKERS WHEN THE DISPLAY TILT MECHANISM IS MOVED. THE PROBLEM OCCURRED DURING A CASE. THE ISSUE DID NOT INTERFERE WITH THE PROCEDURE AND THERE WAS NO PATIENT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| PROBE