BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1315431 · Received February 12, 2009

    Report

    Report Number
    1222780-2009-00018
    Event Type
    Injury
    Date Received
    February 12, 2009
    Date of Event
    January 10, 2009
    Report Date
    January 13, 2009
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THREE RADIO FREQUENCY CONTROLLERS (RFC) WERE RETURNED FOR EVALUATION BECAUSE THE FACILITY DID NOT KNOW WHICH OF THEIR 3 CONTROLLERS WAS IN USE DURING THIS EVENT. DEVICE HISTORY RECORD (DHR) REVIEWS WERE CONDUCTED FOR THE 3 RADIO FREQUENCY CONTROLLERS REPORTED. THERE WERE NO ABNORMALITIES NOTED AND THE DEVICES PASSED ALL INSPECTION CRITERIA FOR RELEASE. DEVICE MFR DATE- 07/2008 (ALL 3 RFC). THE CODING IN THIS SECTION REFLECTS THE EVALUATION OF THE 3 RADIO FREQUENCY CONTROLLERS. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE USED IN THIS PROCEDURE AS A LOT AND SERIAL NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. THE DISPOSABLE DEVICE WAS DISCARDED BY THE FACILITY. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM.

    Description of Event or Problem · 1

    USER FACILITY REPORTED A SUCCESSFUL NOVASURE ABLATION PERFORMED IN EARLY 2009. THE PT RETURNED WITHIN 48 HOURS COMPLAINING OF ABDOMINAL DISCOMFORT. DURING FOLLOW-UP TWELVE DAYS LATER, THE PHYSICIAN REPORTED THE PATIENT CAME TO THE ER WITH ABDOMINAL PAIN AND FEVER AND WAS ADMITTED TO THE HOSPITAL ON TWO DAYS AFTER THE ORIGINAL DATE. "HER WHITE BLOOD CELL COUNT WAS INITIALLY 16,000 AND ROSE TO 19,000."AN EXPLORATORY LAPAROSCOPY WAS DONE AND "A UTERINE PERFORATION WAS NOTED WHICH WAS 0.5 CM IN DIAMETER AND LOCATED HALFWAY BETWEEN THE MIDLINE OF THE FUNDUS AND THE CORNUA. THERE WAS ALSO FOUND TO BE A SMALL BOWEL PERFORATION ASSOCIATED WITH A THERMAL INJURY TO THE BOWEL." TREATMENT INCLUDED A SMALL BOWEL RESECTION WITH RE-ANASTOMOSIS AND A HYSTERECTOMY. "THE PT DID WELL AND WAS DISCHARGED HOME IN STABLE CONDITION." DURING FOLLOW-UP WITH THE PHYSICIAN'S OFFICE ON THE FOLLOWING MONTH, THE PHYSICIAN'S NURSE REPORTED THE PT WAS DISCHARGED FROM THE HOSPITAL ON ORIGINAL MONTH AND SEEN ON FOLLOW-UP, THIRTEEN DAYS LATER, AND IS FINE.

    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 Hospitalization| R RADIO FREQUENCY CONTROLLERS