BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISOLATOR SYNERGY CLAMP

    MDR report key: 1054729 · Received June 2, 2008

    Report

    Report Number
    3003502395-2008-00004
    Event Type
    Other
    Date Received
    June 2, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 12, 2008
    Manufacturer
    ATRICURE, INC.
    Product Code
    GEI
    PMA / PMN Number
    K063630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION OF THIS EVENT WAS REPORTED TO THE COMPANY BY FIELD PERSONNEL. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME BY THE ACCOUNT. EVALUATION SUMMARY: THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED. A RETAINED SAMPLE OF THE DEVICE FROM A SIMILAR LOT WAS EVALUATED. THE RETAINED SAMPLE WAS EVALUATED FOR FUNCTIONALITY. THERE WERE NO ISSUES NOTED FOR THE FUNCTIONALITY OF THE DEVICE. ALSO, THE DEVICE HISTORY RECORD WAS REVIEWED. NO NON-CONFORMANCE REPORTS WERE FOUND.

    Description of Event or Problem · 1

    DURING AN OPEN MITRAL VALVE CASE, A LESION WAS MADE NEAR THE PULMONARY VEIN. AFTER AN ABLATION WAS MADE WITH THE OLL2, SOME BLEEDING WAS NOTED BY THE ABLATION SITE. THE SURGEON REPAIRED THE AREA WITH SUTURE. NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLATOR SYNERGY CLAMP BIPOLAR CLAMP GEI ATRICURE, INC. OLL2 14573

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention