BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATRICURE BIPOLAR SYSTEM

    MDR report key: 1620549 · Received March 3, 2010

    Report

    Report Number
    3003502395-2010-00002
    Event Type
    Death
    Date Received
    March 3, 2010
    Date of Event
    January 19, 2010
    Report Date
    February 25, 2010
    Manufacturer
    ATRICURE, INC.
    Product Code
    GEI
    PMA / PMN Number
    K063630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL# EMR2. ADD'L CATALOG# A000452. (B) (4). PURCHASE RECORDS WERE EVALUATED TO DETERMINE THE MOST RECENT PURCHASE OF EMR2 AND EML2 DEVICES PRIOR TO THE CASE. THE MOST RECENTLY PURCHASED EMR2 LOT NUMBER WAS 16665 - EXPIRATION DATE 08/01/2011, MANUFACTURE DATE 08/2008. THE MOST RECENTLY PURCHASED EML2 LOT NUMBER WAS 16670 - EXPIRATION DATE 08/01/2011, MANUFACTURE DATE 08/2008. EVAL SUMMARY - THE DEVICE INVOLVED IN THE EVENT WERE NOT RETURNED FOR EVAL. A RETAINED SAMPLE OF THE EMR2 DEVICE FROM A SIMILAR LOT WAS EVALUATED AND A RETAINED SAMPLE OF THE EML2 DEVICE FROM THE SAME LOT WAS EVALUATED. THE SAMPLES WERE EVALUATED FOR FUNCTIONALITY. THERE WERE NO ISSUES NOTED FOR THE FUNCTIONALITY OF THE DEVICES. ALSO, THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED. NOTE: THERE WAS NO DEVICE FAILURE AND THE PHYSICIAN DID NOT IMPLICATE ANY ARTICURE DEVICE, BUT WE ELECTED TO FILE THIS CONSERVATIVELY

    Description of Event or Problem · 1

    DURING A PROCEDURE ON (B) (6) 2010, THE PHRENIC NERVE WAS DAMAGED WHILE USING A COMPETITOR'S HARMONIC SCALPEL. THE EMR2 EML2 DEVICES WERE USED SUCCESSFULLY DURING THE PROCEDURE AND WERE NOT IN THE BODY CAVITY WHEN THE INJURY OCCURRED. ON (B) (6) 2010, THE PT THEN UNDERWENT DIAPHRAGMIC-PLICATION TO INCREASE SUPPORT TO THE PT'S DIAPHRAGM. THE PT WAS RELEASED AND WAS AMBULATORY, BUT WAS ADMITTED BACK TO THE HOSPITAL ON (B) (6) 2010 FOR A STROKE DUE TO AN EMBOLISM. THE PT LATER EXPIRED ON (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRICURE BIPOLAR SYSTEM ELECTROSURGICAL CUTTING AND COAGULATION GEI ATRICURE, INC. EML2 16665

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death