BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNW

    MDR report key: 1316616 · Received February 20, 2009

    Report

    Report Number
    1527736-2008-01770
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS CONFIRMED THE CUSTOMER COMPLAINT AND FOUND THE UNIT WAS OUT OF CALIBRATION, WHICH CAUSED GREEN CABLE ERRORS PER THE CUSTOMER COMPLAINT. TO CORRECT THE CUSTOMER COMPLAINT OF GREEN CABLE ERRORS, THE ANALYSIS SITE PERFORMED CALIBRATION. THE ANALYSIS SITE REPLACED THE BLUE CABLE DUE TO THEY FOUND A BROKEN WIRE AT THE BLUE CABLE CONNECTOR, AND THE BLUE CABLE WOULD NOT STAY CONNECTED ONTO THE CONTROL MODULE. THE E-CLIP WAS REPLACED DUE TO IT WAS DAMAGED DURING DISASSEMBLY. AFTER SERVICING THE UNIT PASSED QA FUNCTIONAL TESTING. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED QA INSPECTION. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINED IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ST HOLSTER WAS GIVING "GREEN" ERROR CODES. THE CUSTOMER WAS ABLE TO FINISH THE BREAST BIOPSY USING ANOTHER ST HOLSTER WITH THE SAME PROBE. THERE WERE NO PT CONSEQUENCES REPORTED. ONE DEVICE TO BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE