BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC 20/240V

    MDR report key: 1181745 · Received September 30, 2008

    Report

    Report Number
    3005075853-2008-01991
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 17, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RECEIVED WITH MINOR SCRATCHES. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT. TO CORRECT THE ISSUE, THE ANALYSIS SITE REPLACED THE VACUUM SYSTEM - VSO. PART REPLACED THAT WAS UNRELATED TO THE CUSTOMER COMPLAINT WAS THE UNIBOARD. AFTER SERVICING, THE UNIT PASSED ALL QA TESTING PROCESSES. 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 DURING A BREAST BIOPSY PROCEDURE, AN ERROR CODE L3-021 REPEATEDLY OCCURRED. IT WAS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNED FOR ANALYSIS.

    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