BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1160587 · Received September 11, 2008

    Report

    Report Number
    3005075853-2008-01659
    Event Type
    Malfunction
    Date Received
    September 11, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT. TO CORRECT THE ISSUE, THE ANALYSIS SITE REPLACED THE ROTATIONAL AND TRANSLATIONAL CABLES. PARTS REPLACED THAT WERE UNRELATED TO THE CUSTOMER COMPLAINT WERE THE SAFETY LATCH, MANUAL SPADE ASSEMBLY AND THE TOP FRAME. 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

    IT WAS REPORTED BY THE CUSTOMER THAT NUMEROUS UNK ERROR CODES OCCURRED. IT WAS UNK IF THE ISSUE OCCURRED DURING A BREAST BIOPSY PROCEDURE. NO FURTHER INFO AVAILABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ONE DEVICE IS BEING RETURNED FOR SERVICE.

    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 PROBE| CONTROL MODULE