BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1823852 · Received November 30, 2007

    Report

    Report Number
    1527736-2007-08135
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Date of Event
    November 15, 2007
    Report Date
    November 15, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL 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 DUE TO IT WAS BENT AT THE LEMO CONNECTOR AND WAS CAUSING GREEN CABLE ERRORS. THE SITE WAS UNABLE TO DUPLICATE THE CUSTOMER COMPLAINT OF BLUE CABLE OR WRONG PROBE ERRORS. THE SAFETY LATCH WAS REPLACED DUE TO BEING WORN. THE E-CLIP WAS REPLACED DUE TO 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 INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INITIALIZATION BLUE, GREEN, AND WRONG PROBE ERRORS OCCURRED. THESE ERRORS OCCURRED ALSO DURING THE BREAST BIOPSY. THE SAMPLES WERE TAKEN SUCCESSFULLY. 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) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE| CONTROL MODULE