BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVASURE IMPEDANCE CONTORLLED EA SYSTEM

    MDR report key: 2948122 · Received January 9, 2008

    Report

    Report Number
    1222780-2007-00060
    Event Type
    Other
    Date Received
    January 9, 2008
    Date of Event
    December 10, 2007
    Report Date
    December 10, 2007
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE REPORTED DISPOSABLE NOVASURE DEVICE (LOT #07J03H). CURRENTLY UNABLE TO ESTABLISH RELATIONSHIP DUE TO NO PRODUCT AVAILABLE OR SERIAL NUMBER PROVIDED. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE RF CONTROLLER ((B)(4)) WHICH WAS BUILT IN NOVEMBER 2007. THERE WERE NO REWORKS OR OBSERVATIONS NOTED AT TIME OF MFR AND WAS RELEASED BY QA ON (B)(4) 2007. NO RELATIONSHIP CAN BE ESTABLISHED BETWEEN DHR AND CURRENT COMPLAINT. THE DEVICES INVOLVED IN THIS EVENT WERE NOT RETURNED TO THE MFR; THEREFORE, AN INVESTIGATION COULD NOT BE PERFORMED. NO FURTHER INFORMATION COULD BE OBTAINED, THUS NO CONCLUSION CAN BE DRAWN FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT "APPROXIMATELY 30 SECONDS INTO THE ABLATION (WITH DISPOSABLE NOVASURE DEVICE) PT EXPERIENCED BRADYCARDIA (AND THEN) FLAT LINED. THE PT WAS STABILIZED AND ABLATION RESUMED. APPROXIMATELY 10 SECONDS LATER THE PT HAD A REPEATED RESPONSE. THE PT WAS STABILIZED AND THE ABLATION WAS SUCCESSFULLY COMPLETED WITH A SECOND DISPOSABLE NOVASURE DEVICE. THE PT WAS DISCHARGED POST PROCEDURE AND IS "FINE." IT WAS REPORTED ON (B)(6) 2007, THAT "THE STAFF AND PHYSICIANS FIND NO FAULT WITH THE NOVASURE DEVICE OR RFC (RADIO FREQUENCY CONTROLLER) USED DURING THIS CASE. THE PHYSICIAN... STATED THIS INCIDENT IS PT SPECIFIC AND THE RFC USED (IN THIS CASE) HAS BEEN IN USE MANY TIMES SINCE THIS OCCURRENCE WITHOUT ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTORLLED EA SYSTEM RADIO FREQUENCY ENDOMETRIAL ABLATION MNB CYTYC SURGICAL PRODUCTS NS2000 07J03H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other