BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1395532 · Received May 27, 2009

    Report

    Report Number
    1222780-2009-00052
    Event Type
    Injury
    Date Received
    May 27, 2009
    Report Date
    April 27, 2009
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE OR THE RADIO FREQUENCY CONTROLLER (RFC) AS IDENTIFICATION NUMBERS WERE NO PROVIDED BY THE COMPLAINANT. REFERENCE INTERNAL COMPLAINT.

    Description of Event or Problem · 1

    USER FACILITY REPORTED A THERMAL INJURY FOLLOWING A NOVASURE PROCEDURE, DONE IN 2009. DURING FOLLOW-UP WITH THE PHYSICIAN THE FOLLOWING MONTH, SHE REPORTED THE PATIENT HAD AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION. HOWEVER, THE PATIENT RETURNED IN 1-2 DAYS AFTER THE PROCEDURE WITH AN "ACUTE ABDOMEN" AND WAS TAKEN TO THE OPERATING ROOM. DURING A LAPAROTOMY A "2 CM THERMAL INJURY [WAS] SEEN ON THE SEROSAL SURFACE" OF THE UTERUS. THERE WAS AN "AREA OF SMALL BOWEL WITH RUPTURE [WHICH] HAD EVIDENCE OF THERMAL INJURY AS WELL. THE BOWEL WAS RESECTED AND RE-ANASTOMOSED. THERE WAS NO EVIDENCE OF UTERINE PERFORATION". WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R RADIO FREQUENCY CONTROLLER: SERIAL# UNK