BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1163346 · Received September 10, 2008

    Report

    Report Number
    1527736-2008-03955
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Report Date
    May 5, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE UNIT WAS RETURNED TO THE INTERNATIONAL SERVICE CENTER. THE CUSTOMER'S COMPLAINT HAS BEEN CONFIRMED. BASED UPON THE INQUIRY INFO RECEIVED, VISUAL AND FUNCTIONAL EXAMINATION, THE UNIT WAS FOUND TO REQUIRE, ROTATIONAL AND TRANSLATIONAL CABLES REPLACED, FASTENING MATERIAL EXCHANGED, AND THE UNDERHOUSING WAS REPLACED. THE DATABASE WAS REVIEWED AND NO PRIOR SERVICING HISTORY WAS FOUND, THEREFORE, NO SERVICE HISTORY WAS REVIEW COULD BE DONE. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS SENT FOR REPAIR. IT WAS NOT NOTED IF THE ISSUE OCCURRED DURING A PROCEDURE. NO PT CONSEQUENCE REPORTED. NO FURTHER INFO IS AVAILABLE.

    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 PROBE| CONTROL MODULE