BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLATOR SYNERGY

    MDR report key: 1912741 · Received November 24, 2010

    Report

    Report Number
    3003502395-2010-00008
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 12, 2010
    Manufacturer
    ATRICURE, INC.
    Product Code
    GEI
    PMA / PMN Number
    K063630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE HOSPITAL WAS CONTACTED TO RETURN THE DEVICE FOR EVALUATION, BUT THE DEVICE HAS NOT YET BEEN RECEIVED AND NO FURTHER RESPONSES FOR THE HOSPITAL HAS BEEN RECEIVED. INFORMATION OF THIS EVENT WAS REPORTED TO THE COMPANY BY A 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. DEVICE NOT RETURNED FOR EVALUATION, ANOTHER OLL2 FROM A SIMILAR LOT # WAS EVALUATED AND PERFORMANCE MET SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING THE INITIAL PROCEDURE ON (B)(6) 2010, AN ISOLATOR SYNERGY ELECTROSURGICAL CUTTING AND COAGULATION DEVICE WAS USED. AFTER THE FIRST CLAMP ABLATION, THE LEFT CURVE JAW DID NOT ALIGN WHEN CLAMPED AFTER THE FIRST USE. THIS WAS NOT REPORTED TO ATRICURE AND WE BECAME AWARE OF THIS INCIDENT THROUGH CORRESPONDENCE FROM FDA. THERE WAS NO PATIENT OR USER CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLATOR SYNERGY ELECTROSURGICAL CUTTING/COAGULATION DEV. GEI ATRICURE, INC. OLL2 24594

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other