BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1190792 · Received October 7, 2008

    Report

    Report Number
    3005075853-2008-02179
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 15, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/07/2008. EVAL SUMMARY: THE UNIT WAS RECEIVED WITH MINOR SCRATCHES. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT. TO CORRECT THE ISSUE, THE ANALYSIS SITE REPLACED THE ROTATIONAL AND TRANSLATIONAL CABLES. AFTER SERVICING, THE UNIT PASSED ALL QA TESTING PROCEDURES. 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 THE CUTTER WOULDN'T ROTATE AND NO SAMPLES COULD BE RETRIEVED. THE CASE WAS ABORTED AND RESCHEDULED. THE CASE WAS RESCHEDULED ONCE THE LOANER UNIT WAS RECEIVED. NO CONSEQUENCE OCCURRED. ONE HOLSTER IS BEING RETURNED FOR REPAIR.

    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 CONTROL MODULE| PROBE