BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

    MDR report key: 1820909 · Received October 30, 2007

    Report

    Report Number
    1527736-2007-07167
    Event Type
    Malfunction
    Date Received
    October 30, 2007
    Date of Event
    October 5, 2007
    Report Date
    October 10, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNIBOARD. EVALUATION SUMMARY: THE ANALYSIS SITE CONFIRMED THE CUSTOMER'S COMPLAINT AND FOUND THE CONTROL MODULE WAS GIVING ERROR CODE L1-001 AND KEPT SHUTTING DOWN CAUSING THE LCD TO GO BLANK. THEY ALSO FOUND THE LCD DISPLAY WOULD NOT LOCK IN PLACE. TO CORRECT THE CUSTOMER'S COMPLAINT, THE ANALYSIS SITE REPLACED THE UNIBOARD. THE U-HANDLE WAS REPLACED TO CORRECT LCD DISPLAY LOCK ISSUE. 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 DURING A CASE, THE EX UNIT KEPT SHUTTING DOWN AND THE LCD SCREEN WOULD GO BLANK AND THEN AUTOMATICALLY TURN BACK TO THE VACUUM TEST. THERE WAS NO PT CONSEQUENCE REPORTED. CASE COMPLETED USING THE UNIT. CONTROL MODULE BEING RETURNED FOR REPAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| PROBE