BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    MDR report key: 812397 · Received February 2, 2007

    Report

    Report Number
    9710493-2006-00023
    Event Type
    Injury
    Date Received
    February 2, 2007
    Date of Event
    November 29, 2006
    Report Date
    January 11, 2007
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEA SYSTEM RECORDS DATA FOR EACH PT TREATMENT PROCEDURE, INCLUDING SYSTEM PARAMETERS AND PT 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 APPLICATOR WAS DISPOSED OF BY THE USER, AND THUS COULD NOT BE ANALYZED.

    Description of Event or Problem · 1

    MEA PERFORMED IN A SEPTATE UTERI WITHOUT COMPLICATIONS. PT RETURNED 13 DAYS-POST TREATMENT WITH ABDOMINAL PAIN. LAPAROTOMY REVEALED THERMAL INJURY TO THE BOWEL AND UTERINE PERFORATION IN THE RIGHT CORNUAL AREA. HYSTERECTOMY AND SMALL BOWEL RESECTION PERFORMED. PT HAS RECOVERED WITHOUT FURTHER COMPLICATIONS. CAUSE OF PERFORATION UNK.

    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 YR Required Intervention