BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC- 20/24V

    MDR report key: 1203761 · Received October 10, 2008

    Report

    Report Number
    3005075853-2008-02252
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE UNIT WAS RECEIVED WITH MINOR SCRATCHES. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT. TO CORRECT THE ISSUE. THE ANALYSIS SITE REPLACED THE PRESSURE SENSOR AND THE UNIBOARD AFTER SERVICING, THE UNIT PASSED ALL QA TESTING PROCEDURES. 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 DEVICE SHOWED ERROR L4-033 ON THE SCREEN. IT WAS UNK IF THE ISSUE OCCURRED DURING A PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME CONTROL MODULE WITH SMARTVAC- 20/24V KNW ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE| HOLSTER