BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    MDR report key: 511923 · Received February 16, 2004

    Report

    Report Number
    9710493-2004-00002
    Event Type
    Injury
    Date Received
    February 16, 2004
    Date of Event
    December 29, 2003
    Report Date
    February 16, 2004
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CERVIX WAS DILATED AND UTERUS SOUNDED TO 90 MM IN LENGTH. THE APPLICATOR WAS INTRODUCED, AND CYCLE COMPLETED IN APPROX 3 MINUTES WITHOUT COMPLICATIONS. ABLATIOIN WAS STARTED IN THE FUNDUS FOLLOWED BY BOTH CORNUAL ENDS, AND SUBSEQUENTLY THE REST OF THE UTERINE CAVITY WAS ABLATED IN SYSTEMATIC FASHION WITHOUT COMPLICATIONS. PATIENT RETURNED TO RECOVERY ROOM IN STABLE CONDITION. THE FOLLOWING DAY, PATIENT PRESENTED THEMSELVES TO E.R. WITH ABDOMINAL PAIN (NOT PASSING ANY FLATUS). IV HYDRATION STARTED; WHITE CELL COUNT 14; PATIENT ADMITTED FOR OBSERVATION; STARTED IV ANTIBIOTIC TREATMENT. CT SCAN OF ABDOMEN PERFORMED THE FOLLOWING DAY; CONCERN OF POSSIBLE UNDERLYING BOWEL INJURY. CONTINUED ABDOMINAL DISTENTION AND PATIENT NOT IMPROVING. LAPAROTOMY RECOMMENDED FOR DIAGNOSIS AS WELL AS TREATMENT. PREOPERATIVE DIAGNOSIS; INTRA-ABDOMINAL SEPSIS. LAPAROTOMY PERFORMED REVEALING SMALL BOWEL PERFORATION WITH FULL-THICKNESS NECROSIS. EXAMINATION OF PELVIS, SHOWED AREA OF NECROSIS AND CLOT PRESENT ON THE RIGHT SIDE OF FUNDUS OF THE UTERUS. SURGEONS SUSPECT THAT THERE MAY HAVE BEEN INADVERTENT PERFORATION TO THE FUNDUS OF THE UTERUS AND SUBSEQUENT THERMAL INJURY TO A LOOP OF THESE, AND TO THE LOOPS OF SMALL BOWEL SITTING IN THE PELVIS ADJACENT TO THE PERFORATION SITE. RESECTED 2 SEGMENTS OF SMALL BOWEL, ABOUT 6 TO 8 IN. IN TOTAL LENGTH, AND PERFORMED SIDE-TO-SIDE FUNCTIONAL STAPLED ANASTOMOSIS. PROCEDURE COMPLETED, AND PATIENT IN STABLE CONDITION. SURGEON REPORTED PATIENT RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM MICROWAVE ENDOMETRIAL ABLATION DEVICE MNB MICROSULIS MEDICAL LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R