BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1032239 · Received April 18, 2008

    Report

    Report Number
    1527736-2008-02282
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 20, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 4/18/2008. BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE PERFORMED SERVICE AND FUNCTIONAL TESTS AND FOUND BOTH THE GREEN AND BLUE CABLES WERE BAD AND CAUSING PROBLEMS OF HESITATING, NOT CLOSING ALL THE WAY AND STOPPING DURING THE ACTIVATION PROCESS PER THE CUSTOMER COMPLAINT. TO CORRECT THE CUSTOMER COMPLAINT, THE ANALYSIS SITE REPLACED THE GREEN CABLE AND THE BLUE CABLE. THE SITE ALSO REPLACED THE TOP AND BOTTOM FRAME DUE TO IT HAVING PAINT THAT WAS LOOSE AND CHIPPING OFF, THE SHROUD WAS REPLACED DUE TO IT BEING CRACKED, THE TRANSMISSION CLAMP TOP WAS REPLACED DUE TO THE TAB BEING BROKEN, THE PORT SHAFT WAS REPLACED DUE TO IT BEING BENT AND THE E-CLIP WAS DAMAGED DURING DISASSEMBLY AND WAS REPLACED. AFTER SERVICING, THE UNIT PASSED QA FUNCTIONAL TESTING. 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 GREEN CABLE TO ACTIVATE THE PROBE CUTTER IS HESITATING DURING THE INITIALIZATION PROCESS AND DURING THE ACTIVATION OF THE CUTTER DURING THE SAMPLE MODE DURING A BREAST BIOPSY. THERE HAVE BEEN NO REPORTED ERROR CODES OCCURRING, BUT THE CUTTER IS NOT CLOSING ALL THE WAY AND STOPPING DURING THE ACTIVATION PROCESS. THERE HAVE BEEN NO PT CONSEQUENCES REPORTED. ONE DEVICE TO BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| PROBE