BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME EX HOLSTER

    MDR report key: 1904392 · Received January 30, 2008

    Report

    Report Number
    1527736-2008-00588
    Event Type
    Malfunction
    Date Received
    January 30, 2008
    Report Date
    December 28, 2007
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TRANSVERSE DRIVE SHAFT. EVAL SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND DURING TESTING, THAT THE UNIT HAD CONTAMINATION ON THE DRIVE SHAFT THAT CAUSED SLOW ROTATIONAL TURNING PER THE CUSTOMER COMPLAINT. TO CORRECT THIS ISSUE, THE ANALYSIS SITE REPLACED TWO (2) DRIVE SHAFTS, AND TWO (2) BUSHINGS. THE UNIT HAS NOT BEEN RETURNED FOR SERVICE PRIOR TO THIS EVENT, THEREFORE, NO SERVICE HISTORY REVIEW CAN BE DONE. 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 HOLSTER IS NOT ALLOWING THE PROBE TO CUT THE BREAST TISSUE DURING THE SAMPLE MODE. THE TROUBLESHOOTING INDICATED THAT THE CUTTING FORK WAS NOT SPINNING UPON ACTIVATION. THERE WAS NO PROCEDURE INVOLVEMENT. THERE WERE NO PT CONSEQUENCES REPORTED.

    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 CONTROL MODULE| PROBE