BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME EX HOLSTER

    MDR report key: 1152729 · Received September 10, 2008

    Report

    Report Number
    1527736-2008-03736
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 3, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K033700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/16/2008. TRANSVERSE DRIVE SHAFT. BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE AN MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND INTERNAL CONTAMINATION OF THE TRANSLATIONAL DRIVE SHAFT CAUSED NO CUTTER MOVEMENT PER THE COMPLAINT. TO CORRECT THE CUSTOMER COMPLAINT THE ANALYSIS SITE REPLACED TWO DRIVE SHAFTS AND TWO BUSHINGS. THE POWER CABLE LEMO CONNECTOR WAS DAMAGED AND TO CORRECT THIS ISSUE THE SITE REPLACED THE POWER CABLE. PER THE SERVICE MANUAL, SERVICE TESTS WERE PERFORMED AND THE UNIT PASSED ALL TESTS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED ALL QA INSPECTIONS. 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 BREAST BIOPSY THE PROBES CUTTER WOULD NOT RETRACT PROPERLY BUT THE LCD SCREEN INDICATED THE CUTTER WAS FULLY RETRACTED. THERE WAS NO PT CONSEQUENCE REPORTED. CASE WAS COMPLETED USING THE UNIT AND HOSLTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME EX HOLSTER KNW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE| CONTROL MODULE