BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1830330 · Received August 10, 2007

    Report

    Report Number
    1527736-2007-05316
    Event Type
    Malfunction
    Date Received
    August 10, 2007
    Date of Event
    July 24, 2007
    Report Date
    July 24, 2007
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: BASED UPON THE INQUIRY INFO RECEIVED VISUAL AND FUNCTIONAL EXAMINATION: THE UNIT WAS FOUND TO REQUIRE GREEN CABLE TO BE REPLACED. THE DEVICE WAS FUNCTIONALLY TESTED, MET ALL PRODUCT REQUIREMENTS AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROBE RECEIVED AN L3-002 ERROR DURING INITIALIZATION. THE CUSTOMER STRAIGHTENED THE CABLING, RESEATED THE CONNECTORS, NOTICED THE GREEN CABLE CONNECTOR WAS LOOSE-FITTING, HELD THE CONNECTOR IN PLACE, ATTEMPTED TO INITIALIZE THE PROBE AND RECEIVED ANOTHER L3-002 ERROR. A SECOND PROBE WAS TRIED, INITIALIZED SUCCESSFULLY, AND THE CASE WAS COMPLETED WITH NO PT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE| CONTROL MODULE