BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNW

    MDR report key: 1316696 · Received February 20, 2009

    Report

    Report Number
    1527736-2008-01402
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND A BROKEN/DAMAGED GREEN CABLE AT THE CONNECTOR, CAUSING THE UNIT TO HAVE GREEN CABLE ERRORS, WHEN ACTIVATED PER THE CUSTOMER COMPLAINT. TO CORRECT THE COMPLAINT THE ANALYSIS SITE REPLACED THE GREEN CABLE. THE E-CLIP WAS REPLACED DUE TO IT WAS DAMAGED DURING DISASSEMBLY. AFTER SERVICING THE UNIT PASSED QA FUNCTIONAL TESTING. THE UNIT HAS NOT BEEN RETURNED FOR SERVICE PRIOR TO THIS EVENT. THEREFORE NO SERVICE HISTORY VIEW 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 A BREAST BIOPSY A GREEN CABLE ERROR CODE WAS RECEIVED AND THEN IT WAS NOTICED THAT THE GREEN CABLE IS STARTING TO COME APART. THERE WAS NO PT CONSEQUENCE REPORTED, CASE WAS COMPLETED USING THE HOLSTER. ST HOLSTER BEING RETURNED FOR REPAIR.

    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 PROBE| CONTROL MODULE