BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1823890 · Received November 30, 2007

    Report

    Report Number
    1527736-2007-08144
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Date of Event
    November 16, 2007
    Report Date
    November 16, 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
    NY, 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 PORT SHAFT, COIL PIN, ROTATING KNOB, DUE TO THE PORT SHAFT WAS BENT. THE E-CLIP WAS REPLACED DUE TO IT WAS DAMAGE DURING DISASSEMBLY. AFTER SERVICING, THE UNIT PASSED ALL QA FUNCTIONAL TESTING. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED QA INSPECTION. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS THAT UPON POWERING THE UNIT ERROR CODES WERE RECEIVED. THE ACCOUNT WAS UNABLE TO GET THE ERROR CODES TO DISAPPEAR. NO PT OR CASE INVOLVEMENT.

    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