BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME EX HOLSTER

    MDR report key: 1121913 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01163
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    KNW
    PMA / PMN Number
    K033700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRANSVERSE DRIVE SHAFT. EVALUATION SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT, AND FOUND THAT INTERNAL CONTAMINATION BETWEEN THE DRIVE SHAFTS AND BUSHINGS WAS CAUSING SLOW CUTTER MOVEMENT, AND A GRINDING NOISE PER THE CUSTOMER COMPLAINT. TO CORRECT THIS ISSUE, THE ANALYSIS SITE REPLACED TWO DRIVE SHAFTS AND TWO BUSHINGS. PER THE SERVICE MANUAL, SERVICE TESTS WERE PERFORMED WITH NO FUNCTIONAL FAULTS FOUND. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER STATING THAT THEIR EX HOLSTER IS NOT WORKING PROPERLY. DURING A BREAST BIOPSY PROCEDURE THEY HEARD A GRINDING NOISE AND NOTICED THAT THEIR PROBES CUTTER WAS NOT ADVANCING OR RETRACTING PROPERLY. THEY CHANGED PROBES AND CONTINUED THE CASE WITH NO CONSEQUENCE TO THE PT. EX HOLSTER BEING RETURNED FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME EX HOLSTER KNW ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| PROBE