BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1527736-2008-00581

    MDR report key: 1904390 · Received January 30, 2008

    Report

    Report Number
    1527736-2008-00581
    Event Type
    Malfunction
    Date Received
    January 30, 2008
    Date of Event
    January 9, 2008
    Report Date
    January 9, 2008
    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
    TN, 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 DURING TESTING FOUND THE GREEN CABLE WAS CAUSING THE UNIT TO HAVE ERROR L3-017 INTERMITTENTLY PER THE COMPLAINT. TO CORRECT THE CUSTOMER COMPLAINT, THE SITE REPLACED THE GREEN CABLE. DURING TESTING, IT WAS ALSO FOUND THAT THE TOP AND BOTTOM FRAME WERE BROKEN, AND TO CORRECT THIS ISSUE, THE SITE REPLACED THE TOP AND BOTTOM FRAME. A BENT PORT SHAFT AND COIL PIN WAS CAUSING THE REAR ROTATION KNOB TO BE WOBBLY AND THE ANALYSIS SITE REPLACED THE PORT SHAFT AND COIL PIN TO CORRECT THE ISSUE. THE E-CLIP WAS DAMAGED DURING DISASSEMBLY AND WAS REPLACED. 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 REPORTED THAT MULTIPLE ERROR CODES WERE OCCURRING DURING THE BREAST BIOPSY, L3-017 & L3-007. THERE WAS NO PT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE