BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 20/240V

    MDR report key: 1181741 · Received September 30, 2008

    Report

    Report Number
    3005075853-2008-01993
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Report Date
    August 25, 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
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 09/30/2008. EVALUATION SUMMARY - THE UNIT WAS RECEIVED WITH MINOR SCRATCHES. BASED UPON THE INQUIRY INFORMATION RECEIVED, VISUAL AND FUNCTIONAL EXAMINATION, THE CUSTOMER'S COMPLAINT HAS BEEN CONFIRMED. TO CORRECT THE ISSUE, THE ANALYSIS SITE REPLACED THE VACUUM PUMP AND UNIBOARD. AFTER SERVICING, THE UNIT PASSED ALL QA TESTING PROCESSES. THE DATABASE WAS REVIEWED AND NO PRIOR SERVICING HISTORY WAS FOUND, THEREFORE NO SERVICE HISTORY REVIEW COULD BE DONE. COMPLAINT INFORMATION 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 SENT TO THEM BECAUSE AN L3 021 ERROR CODE WAS RECEIVED. IT WAS NOT REPORTED IF THE CODE DISPLAYED DURING A BREAST BIOPSY PROCEDURE. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME CONTROL MODULE WITH SMARTVAC - 20/240V KNW ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| PROBE