BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1013346 · Received March 13, 2008

    Report

    Report Number
    1222780-2008-00028
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER AND WAS DETERMINED TO BE VALID. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION DUE TO NO PROD AVAILABLE OR SERIAL NUMBER PROVIDED. ACCORDING TO THE IFU UNDER THE WARNINGS SECTION: 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 JUDGEMENT TO DETERMINE WHETHER OR NOT FURTHER DILATION IS REQUIRED. THE NOVASURE SYS 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. (STEP 2.36). ALTHOUGH DESIGNED TO DETECT A PERFORATION OF THE UTERINE WALL, IT (CIA ALARM) IS AN INDICATOR ONLY AND IT MIGHT NOT DETECT ALL PERFORATIONS UNDER ALL POSSIBLE CIRCUMSTANCES. CLINICAL JUDGEMENT MUST ALWAYS BE USED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT DURING PLACEMENT OF A DISPOSABLE NOVASURE DEVICE, THE PHYSICIAN FELT A"GIVE" AND THE CAVITY INTEGRITY ASSESSMENT (CIA) TEST WAS UNSUCCESSFUL. THE PROCEDURE WAS ABORTED AND A HYSTEROSCOPY REVEALED A PERFORATION IN THE CORNUA. TREATMENT INCLUDED "A STAT DOSE" OF PROPHYLACTIC ANTIBIOTICS "CEPHAZOLIN/METRONIDAZOLE". ADD'L INFO WAS RECEIVED ON 03/11/08 FROM THE PHYSICIAN. HE REPORTED THE PT WAS "DISCHARGED ASYMPTOMATIC AND WITH NO SEQUELAE TO EVENT". HE REPORTED SHE WAS ASYMPTOMATIC AT FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM RADIO FREQUENCY ENDOMETRIAL ABLATION MNB CYTYC SURGICAL PRODUCTS NS2000 07G30H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other