BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVASURE RF CONTROLLER

    MDR report key: 766800 · Received September 29, 2006

    Report

    Report Number
    MW1040540
    Event Type
    Other
    Date Received
    September 29, 2006
    Date of Event
    September 27, 2006
    Report Date
    September 27, 2006
    Manufacturer
    CYTYC LP
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEW REP FROM CYTYC. THE NOVASURE RF CONTROLLER HAD A VACUUM LIGHT GO ON. REP UNSURE HOW TO CORRECT & PLACED CALL TO COMPANY. ROOM STAFF PUSHED ENABLE BUTTON AND MACHINE WORKED. REP CONTINUED CASE. NOVASURE DEVICE DEPLOYED. ONLY DEPLOYED FOR ~5 SEC & SYSTEM STOPPED, INDICATING COMPLETION. UTERUS CHECKED AND DID NOT APPEAR ABLATED. REP STATED COULDN'T REPEAT PROCEDURE. PT RECOVERED TO PACU. GYN SPECIALIST (RN) CONSULTED, WHO THEN CALLED OLD REP WHO IMMEDIATELY CAME ON-SITE. PT INFORMED BY DOCTOR OF MACHINE MALFUNCTION & PT OPTED TO HAVE PROCEDURE REPEATED SAME DAY. SECOND PROCEDURE PERFORMED AND UTERUS ABLATED. OLD REP STATED AS SHE WAS LEAVING THAT VACUUM LIGHT ALARM HAD GONE ON AGAIN, BUT SHE WAS ABLE TO CORRECT IT, THIS TIME IT DID NOT INTERFERE WITH SECOND PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE RF CONTROLLER FOR ABLATION OF ENDOMETRIAL LINING OF UTERUS MNB CYTYC LP REC2008-115 *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other