BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1941790 · Received December 22, 2010

    Report

    Report Number
    1222780-2010-00207
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    April 25, 2010
    Report Date
    November 25, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT. NEITHER THE DEVICE NOR RADIO FREQUENCY CONTROLLER IS BEING RETURNED; THEREFORE, A FAILURE ANALYSIS OF THIS NOVASURE SYSTEM CANNOT BE COMPLETED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. (B)(4).

    Description of Event or Problem · 1

    FOLLOWING A HYSTEROSCOPY, A DILATATION AND CURETTAGE (D&C) AND AN UNEVENTFUL NOVASURE PROCEDURE PERFORMED ON (B)(6) 2010 ON A PT WITH AN "ACUTELY ANTEVERTED UTERUS", A LAPAROSCOPY WAS PERFORMED WHICH NOTED AN "AREA OF WHITE TISSUE DESICCATION SIMILAR TO A BURN NEAR THE LEFT CORNUA" WITH NO UTERINE PERFORATION OR BOWEL INJURY. NO TREATMENT WAS NEEDED AND A SCHEDULED BILATERAL TUBAL LIGATION WITH FILSHIE CLIPS WAS PERFORMED. ON (B)(6) 2010, THE PT PRESENTED WITH A "FAIRLY ACUTE ONSET OF ABDOMINAL PAIN". BOTH AN ULTRASOUND AND X-RAY WERE PERFORMED WITH NO FINDINGS OF INFECTION OR FREE FLUID IN THE ABDOMEN. THE PT HAD INCREASING ABDOMINAL PAIN AND WAS ADMITTED TO THE HOSPITAL. A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED FREE AIR IN THE ABDOMEN AND THE PT GOT PROGRESSIVELY SICKER AND BECAME FEBRILE, AND TACHYCARDIC (140 BEATS PER MINUTE). SHE WAS ALSO FOUND TO HAVE A "RIGID ABDOMEN". A LAPAROTOMY WAS PERFORMED WHICH NOTED "PURULENT DRAINAGE" FROM THE ABDOMEN. A PERFORATION IN THE SMALL BOWEL WAS NOTED "APPROX 2 CM INSIDE [AND] APPROX 3 FEET FROM THE ILEOCECAL JUNCTION". THE SMALL BOWEL DEFECT WAS "CLAMPED AND APPROX A 4 INCH SECTION OF THE SMALL BOWEL WAS EXCISED AND REAPPROXIMATED". A 0.5 X 3CM PERFORATION IN THE LEFT POSTERIOR CORNEAL REGION OF THE UTERUS WAS ALSO NOTED. THIS PERFORATION WAS OVERSEWN. THE RIGHT POSTERIOR CORNEAL REGION HAD A "THINNING AREA THAT APPEARED TO BE A THERMAL DEFECT, BUT IT DID NOT GO FULL THICKNESS." THE PT WAS PLACED ON "IV PIPERACILLIN/TAZOBACTAM". SHE REPORTEDLY "DID EXTREMELY WELL AND RAPIDLY RECOVERED WITHOUT ANY SIGNS OF ONGOING SEPSIS" AND WAS DISCHARGED ON (B)(6) 2010. DIAGNOSIS UPON DISCHARGE WAS "PERITONITIS SECONDARY TO UTERINE AND SMALL BOWEL PERFORATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 09M11RA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK