BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1170284 · Received September 12, 2008

    Report

    Report Number
    3005075853-2008-01682
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 09/18/2008. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT. TO CORRECT THE ISSUE, THE ANALYSIS SITE REPLACED THE ROTATIONAL CABLE, COIL PIN AND PORT SHAFT. PARTS REPLACED THAT WERE UNRELATED TO THE CUSTOMER COMPLAINT WERE THE SAFETY LATCH AND THE ELECTRICAL CABLE. AFTER SERVICING, THE UNIT PASSED ALL QA TESTING PROCESSES. COMPLAINT INFORMATION 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 HOLSTER WAS MAKING A STRONG AND UNUSUAL VIBRATION ON THE BLUE CABLE DURING THE 'SAMPLE MODE' SETTING PRIOR TO A BREAST BIOPSY PROCEDURE. THERE HAVE BEEN NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTOME ST HOLSTER/CABLES KNW ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CONTROL MODULE| PROBE