BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1823705 · Received December 11, 2007

    Report

    Report Number
    1527736-2007-08393
    Event Type
    Malfunction
    Date Received
    December 11, 2007
    Date of Event
    November 27, 2007
    Report Date
    November 27, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND TO CORRECT THE COMPLAINT THE SITE REPLACED THE GREEN CABLE. THE SITE ALSO REPLACED THE PORT SHAFT AND COIL PIN DUE TO THEY WERE BENT, THE E-CLIP WAS REPLACED BECAUSE IT WAS DAMAGED DURING DISASSEMBLY. AFTER SERVICING THE UNIT PASSED ALL QA FUNCTIONAL TESTING. THE UNIT HAS NOT BEEN RETURNED FOR SERVICE PRIOR TO THIS EVENT, THEREFORE NO SERVICE HISTORY REVIEW CAN BE DONE. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ERROR CODE OF L3-002 POPULATING ON THREE DIFFERENT PROBES. THE TROUBLESHOOTING HAS INDICATED AN ACTIVATION PROBLEM WITH PROBE DURING INITIALIZATION. THE PATIENT WAS RESCHEDULED FOR ANOTHER TIME.

    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 CONTROL MODULE