BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2803060 · Received October 17, 2012

    Report

    Report Number
    1222780-2012-00222
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RADIO FREQUENCY CONTROLLER RETURNED FOR EVALUATION ON (B)(4) 2012. DEVICE HISTORY RECORDS (DHR) REVIEWS WERE CONDUCTED FOR THE DISPOSABLE DEVICE AND RFC. NO ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFORMATION. THE DEVICES PASSED FINAL TESTING PRIOR TO RELEASE MEETING ALL SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    FOLLOWING THE REMOVAL OF A "SMALL POLYP" WITH SCISSORS AND GRASPERS AND THEN "SOME CURETTING" THE PHYSICIAN ATTEMPTED A NOVASURE ENDOMETRIAL ABLATION ON AN ANTEVERTED UTERUS. THE PHYSICIAN HAD DIFFICULTY SEATING THE ARRAY AND ENCOUNTERED A VACUUM ALARM 20 SECONDS INTO THE ABLATION AND DECIDED TO A HYSTEROSCOPY. VISUALIZATION WAS POOR DUE TO DUE LACK OF UTERINE DISTENTION AND A LAPAROSCOPY WAS DONE. THE PHYSICIAN NOTED A "1CM PERFORATION AT THE UTERINE FUNDUS WITH SEROSAL CHARRING AND BLANCHING". THE BOWEL WAS INSPECTED BY THE PHYSICIAN AND A GENERAL SURGEON AND NO INJURY WAS NOTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OVERNIGHT OBSERVATION. THE PATIENT DID WELL AND WAS DISCHARGED HOME THE NEXT DAY. THE PATIENT RETURNED 36 HOURS LATER ((B)(6) 2012) WITH "ACUTE ABDOMINAL PAIN" AND VOMITING AND WAS READMITTED. FOLLOWING A COMPUTED TOMOGRAPHY (CT) SCAN A LAPAROTOMY WAS DONE AND A PERFORATION, "ASSOCIATED WITH THERMAL INJURY", WAS FOUND ON THE SMALL BOWEL. THE AREA WAS RESECTED AND A RE-ANASTOMOSIS WAS PERFORMED. THE PATIENT WAS HOSPITALIZED FOR 5 DAYS AND DISCHARGED HOME IN STABLE CONDITION. ON (B)(6) 2012, THE PHYSICIAN REPORTED THE PATIENT IS CURRENTLY "DOING FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 11L08RA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R SERIAL NUMBER (B)(4)| RADIO FREQUENCY CONTROLLER