BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    MDR report key: 1285762 · Received January 9, 2009

    Report

    Report Number
    9710493-2008-00008
    Event Type
    Injury
    Date Received
    January 9, 2009
    Date of Event
    August 5, 2008
    Report Date
    January 8, 2009
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE MANUFACTURE DATE: SYSTEM 06/2004. THE MEA SYSTEM RECORDS DATA FOR EACH PATIENT TREATMENT PROCEDURE, INCLUDING SYSTEM PARAMETERS AND PATIENT DATA ENTERED BY THE PHYSICIAN. THE COMPANY ANALYZED THE MEA SYSTEM'S TREATMENT DATA FILE ASSOCIATED WITH THIS EVENT. THE CONCLUSION OF THE ANALYSIS WAS THAT THE MEA SYSTEM WAS FUNCTIONING WITHIN OPERATING SPECIFICATIONS AT THE TIME OF THE TREATMENT, AND NO MALFUNCTIONS OR PERFORMANCE DEVIATIONS WERE PRESENT. THE MEA IFU CONTRAINDICATES TREATMENT IN A PATIENT WITH A MYOMETRIAL WALL THICKNESS LESS THAN 10 MM. THE IFU PROVIDES DIRECTION ON MEASURING THE MYOMETRIAL WALL THICKNESS WITH THE USE OF TRANSVAGINAL ULTRASOUND.

    Description of Event or Problem · 1

    PATIENT WAS TREATED WITH A REUSABLE APPLICATOR. IMMEDIATELY FOLLOWING THE MEA PROCEDURE, A SCHEDULED LAPAROSCOPIC TUBAL LIGATION WAS PERFORMED. AT THE TIME OF THE LAPAROSCOPY, A THERMAL INJURY 2X1 CM WAS NOTED ON THE ANTERIOR SURFACE OF THE UTERUS BUT NO APPARENT INJURY TO THE BOWEL WAS IDENTIFIED AT THIS TIME. THE PATIENT WAS DISCHARGED WITH ANTIBIOTICS THE FOLLOWING DAY, HOWEVER, WAS READMITTED 4 DAYS POST MEA WITH COMPLAINT OF ABDOMINAL PAIN. SEVEN DAYS POST MEA, LAPAROSCOPY WAS PERFORMED AND SHOWED "A BREAKDOWN OF THE THERMAL INJURY WITH A FISTULA FROM THE UTERUS TO THE PERITONEUM." THE PATIENT SUBSEQUENTLY UNDERWENT LAPAROTOMY, HYSTERECTOMY AND OVERSEWING OF A 5MM BOWEL PERFORATION. THE PATIENT HAD AN UNEVENTFUL RECOVERY.

    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 NA Required Intervention