BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME EX HOLSTER

    MDR report key: 1080339 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00358
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRANSVERSE DRIVE SHAFT. EVAL SUMMARY: BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND CONTAMINATION BETWEEN THE DRIVE SHAFTS AND BUSHINGS WAS CAUSING THE L3 ERROR CODE. TO CORRECT THE CUSTOMER COMPLAINT THE ANALYSIS SITE REPLACED TWO DRIVE SHAFTS AND TWO BUSHINGS. PER THE SERVICE MANUAL PERFORMED SERVICE TESTS, NO FUNCTIONAL FAULTS WERE FOUND. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED QA INSPECTION. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED THAT THE ERROR CODE WAS REC'D WITH THE HOLSTER PRIOR TO A BREAST BIOPSY. THE PROCEDURE WAS CANCELLED AND RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME EX HOLSTER NONE KNW ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| PROBE