BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3800266 · Received May 1, 2014

    Report

    Report Number
    1222780-2014-00073
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF THE DEVICE IS RETURNED AND EVAL COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE DISPOSABLE NOVASURE DEVICE AND THE RADIO FREQUENCY CONTROLLER. BOTH DEVICES WERE RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN COMPLETED A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) YEAR OLD G2P2 PT WITH NO SIGNIFICATION PAST MEDICAL OR SURGICAL HISTORY. SHE HAD A HISTORY OF ABNORMAL UTERINE BLEEDING. THE PT DESIRED PERMANENT CONTRACEPTION AND WAS SCHEDULED FOR A LAPAROSCOPIC TUBAL STERILIZATION AT THE TIME OF THE NOVASURE ABLATION. THE DEVICE WAS PLACED WITHOUT DIFFICULTY INTO THE UTERINE CAVITY AND SEATED TO A WIDTH OF 4.3CMS. AFTER COMPLETING THE ABLATION, THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND THE DR. PERFORMED A LAPAROSCOPY. AT LAPAROSCOPY, HE IDENTIFIED BILATERAL CIRCUMFERENTIAL THERMAL BURNS ON THE SEROSA OF THE UTERINE SURFACE MEDIAL TO EACH CORNUAL REGION. AFTER COMPLETING A BILATERAL SALPINGECTOMY IN ADDITION TO CAUTERIZATION AND RESECTION OF ENDOMETRIOTIC IMPLANTS, A GENERAL SURGEON WAS CONSULTED FOR INSPECTION OF THE BOWEL. TWO AREAS ON THE SMALL BOWEL WERE IDENTIFIED CONSISTENT WITH THERMAL INJURY. THERE WERE TWO OTHER AREAS WHICH WERE ALSO SUSPICIOUS FOR INJURY. A BOWEL RESECTION WAS PERFORMED WITH END-TO-END ANASTOMOSIS. THE PT WAS ADMITTED TO THE HOSPITAL AND REMAINED STABLE WITH UNCOMPLICATED POST-OPERATIVE COURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261159 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC NS2000 13K30RC

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R RADIO FREQUENCY CONTROLLER - 31356J10D0