BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICURE BIPOLAR SYSTEM

    MDR report key: 1616052 · Received February 19, 2010

    Report

    Report Number
    3003502395-2010-00001
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    January 18, 2010
    Report Date
    February 16, 2010
    Manufacturer
    ATRICURE, INC.
    Product Code
    GEI
    PMA / PMN Number
    K063630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION OF THIS EVENT WAS REPORTED TO THE COMPANY BY A FIELD PERSONNEL AND THE USER FACILITY. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME BY THE ACCOUNT. THIS REPORT WAS GENERATED IN RESPONSE TO AN FDA INQUIRY WHERE THE USER FACILITY SENT A 3500A FORM TO THE FDA. ATRICURE DOES NOT BELIEVE THIS ISSUE WARRANTS AN MDR. AT THIS TIME, THE ACTUAL LOT NUMBER OF THE OLL2 DEVICE INVOLVED IS UNKNOWN. PURCHASE RECORDS WERE EVALUATED TO DETERMINE THE MOST RECENT PURCHASE OF OLL2 DEVICES PRIOR TO THE CASE. THE MOST RECENTLY PURCHASED OLL2 LOT NUMBER WAS 21461 - EXPIRATION DATE 11/01/2012, MANUFACTURE DATE 11/2009. EVALUATION SUMMARY - THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. A RETAINED SAMPLE OF THE DEVICE FROM A SIMILAR LOT WAS EVALUATED. THE SAMPLE WAS EVALUATED FOR FUNCTIONALITY. THERE WERE NO ISSUES NOTED FOR THE FUNCTIONALITY OF THE DEVICE. ALSO, THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    AFTER PLUGGING IN THE OLL2 DEVICE, THE SURGEON ATTEMPTED TO ABLATE, BUT THE DEVICE FAILED TO FUNCTION. THEREFORE, ANOTHER OLL2 WAS OPENED AND THIS DEVICE FUNCTIONED PROPERLY. THERE WAS NO HARM TO THE PATIENT AND NO LONG TERM PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRICURE BIPOLAR SYSTEM ELECTROSURGICAL CUTTING AND COAGULATION GEI ATRICURE, INC. OLL2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other