BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNW

    MDR report key: 1316921 · Received February 20, 2009

    Report

    Report Number
    1527736-2008-02135
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 04/07/2008. EVAL SUMMARY: BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE UNIT WAS RETURNED TO THE INT'L SVC CENTER. BASED UPON THE INQUIRY INFO REC'D VISUAL AND FUNCTIONAL EXAMINATION, THE UNIT WAS FOUND TO REQUIRE THE GREEN (TRANSLATIONAL) CABLE REPLACED. AFTER SERVICING THE UNIT PASSED QA FUNCTIONAL TESTING. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED VIA THE DATABASE. THE UNIT HAS PASSED QA INSPECTIONS. 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 HOLSTER HAD A DAMAGED GREEN CABLE SHEATH. THERE IS NO ADD'L INFO AVAILABLE. THERE WAS NO PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNW KNW ETHICON ENDO SURGERY, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| PROBE