BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1972214 · Received January 19, 2011

    Report

    Report Number
    1222780-2011-00012
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE EXPIRATION DATE OF THE DISPOSABLE NOVASURE DEVICE IS NOT KNOWN. THE DISPOSABLE DEVICE HAS NOT YET BEEN RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE HAS NOT YET BEEN COMPLETED. THE RADIO FREQUENCY CONTROLLER IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE CONTROLLER CAN NOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE MANUFACTURE DATE OF THE DEVICE IS NOT KNOWN. MANUFACTURE DATE OF THE RADIO FREQUENCY CONTROLLER IS (B)(6) 2009. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE AS A LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE RADIO FREQUENCY CONTROLLER (SERIAL# (B)(4)). THE DEVICE WAS RELEASED MEETING ALL SPECIFICATIONS. NO RELATIONSHIP CAN BE ESTABLISHED BETWEEN DHR AND CURRENT COMPLAINT. IF ADDITIONAL RELEVANT INFO OR THE DEVICE IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    FOLLOWING A "SUCTION D&C [DILATATION AND CURETTAGE]" AND A NOVASURE ENDOMETRIAL ABLATION THE PHYSICIAN DID A LAPAROSCOPY FOR THE PURPOSE OF PERFORMING A TUBAL STERILIZATION. SHE NOTED "A BLANCHED AREA ON THE POSTERIOR ASPECT OF THE UTERINE FUNDUS WITHOUT EVIDENCE OF PERFORATION. ADDITIONALLY, SHE SAW A 1CM AREA OF BLANCHING ON THE RECTO-SIGMOID COLON". TREATMENT INCLUDED "PLACING A JACKSON PRATT (JP) DRAIN THROUGH ONE OF THE LAPAROSCOPIC TROCAR SITES FOR ONE WEEK", ADMINISTRATION OF FLAGYL (METRONIDAZOLE), DOSE UNK, AND A LIQUID DIET. THE PT WAS DISCHARGED HOME. ON (B)(6) 2011, THE PHYSICIAN REPORTED "THE PT IS DOING GREAT, NO PROBLEMS, NO ISSUES OR CONCERNS AT ALL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention RADIO FREQUENCY CONTROLLER| SERIAL NUMBER (B)(4)