BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTYC/HOLOGIC SURGICAL PRODUCTS

    MDR report key: 1234511 · Received November 14, 2008

    Report

    Report Number
    MW5009004
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 13, 2008
    Manufacturer
    HOLOGIC LP
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED FOR HYSTEROSCOPY, D&C AND NOVASURE ABLATION. NOVASURE UNIT WAS ATTEMPTED 10 X AND WOULD NOT COMPLETE. ANOTHER DEVICE USED TO COMPLETE PROCEDURE. PRODUCT REP. STATED THAT ALTERATIONS TO DISPOSABLE PIECE NECESSARY TO COMPLETE. HE STATED OTHER COMPLAINTS HAD OCCURRED. NO ALERT LETTER WAS SENT TO FACILITY. THAT PROCEDURE HAD NOT BEEN NECESSARY IN THE PAST. WE HAVE BEEN USING THIS DEVICE FOR SEVERAL YEARS WITHOUT DIFFICULTY. WE HAD ATTEMPTED 2 SEPARATE DISPOSABLE TIPS AND NEITHER WOULD WORK. WHEN REP. STATED CHANGES WERE NECESSARY TO GET PRODUCT TO WORK, I FELT DEVICE NEEDED TO BE REPORTED. I CANNOT SAY FOR SURE THAT THIS PATIENT'S POST-OP BLEEDING AND SUBSEQUENT HOSPITALIZATION WAS DUE TO THE DEVICE FAILURE, BUT FELT IT NECESSARY TO INCLUDE THAT IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYTYC/HOLOGIC SURGICAL PRODUCTS NOVASURE ABLATION CATHETERS MNB HOLOGIC LP 08B05HA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization