BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1328890 · Received February 27, 2009

    Report

    Report Number
    1222780-2009-00023
    Event Type
    Injury
    Date Received
    February 27, 2009
    Date of Event
    January 28, 2009
    Report Date
    January 28, 2009
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WOULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE AS A LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) UNDER CONTRAINDICATIONS: THE NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM IS CONTRAINDICATED FOR USE IN A PT WITH ANY ANATOMIC OR PATHOLOGIC CONDITION IN WHICH WEAKNESS OF THE MYOMETRIUM COULD EXIST, SUCH AS HISTORY OF PREVIOUS CLASSICAL CESAREAN SECTION. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) UNDER THE WARNINGS: USE CAUTION NOT TO PERFORATE THE UTERINE WALL WHEN SOUNDING, DILATING, OR INSERTING THE DISPOSABLE DEVICE. IF THE DISPOSABLE DEVICE IS DIFFICULT TO INSERT INTO THE CERVICAL CANAL, USE CLINICAL JUDGMENT TO DETERMINE WHETHER OR NOT FURTHER DILATION IS REQUIRED. THE NOVASURE SYSTEM PERFORMS A CAVITY INTEGRITY ASSESSMENT (CIA) TEST TO EVALUATE THE INTEGRITY OF THE UTERINE CAVITY, AND SOUNDS AN ALARM WARNING OF A POSSIBLE PERFORATION PRIOR TO TREATMENT.

    Description of Event or Problem · 1

    USER FACILITY REPORTED A UTERINE PERFORATION FOLLOWING AN ATTEMPTED NOVASURE ABLATION. DURING FOLLOW-UP IN EARLY 2009, IT WAS REPORTED THE PERFORATION WAS CONFIRMED VIA LAPAROSCOPE WHICH WAS IN-SITU DURING THE ATTEMPTED ABLATION. TWO PERFORATION SITES WERE SEEN AT THE FUNDUS, EACH APPROXIMATELY 2-3 MM IN SIZE. EACH SITE WAS CAUTERIZED. THE PT WAS KEPT OVERNIGHT FOR OBSERVATION AND DISCHARGED THE NEXT DAY. IT WAS REPORTED "THE PERFORATION WAS DUE TO THE UTERUS [HAVING] BEEN WEAKENED BY PREVIOUS SURGERY". DURING FOLLOW-UP THE FOLLOWING MONTH, IT WAS REPORTED THE CONSULTANT (PHYSICIAN) HAS SPOKEN WITH THE PT BY PHONE AND THE PT "IS BACK TO NORMAL". A HYSTEROSCOPY, DILATATION AND CURETTAGE (D&C), UTERINE BIOPSY, AND SOUNDING WITH A METAL SOUND (NOT A HOLOGIC DEVICE) WERE PERFORMED PRIOR TO THE ATTEMPTED ABLATION.

    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 39 YR Hospitalization| R SERIAL NUMBER - UNK| RADIO FREQUENCY CONTROLLER