BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    MDR report key: 1598379 · Received January 19, 2010

    Report

    Report Number
    9710493-2009-00008
    Event Type
    Injury
    Date Received
    January 19, 2010
    Date of Event
    November 24, 2009
    Report Date
    January 8, 2010
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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

    REPORT OF AN ADVERSE EVENT ASSOCIATE WITH A SINGLE USE MEA APPLICATOR WAS REPORTED ON DECEMBER 8, 2009. THE PT RETURNED 24 HOURS AFTER THE MEA PROCEDURE WITH COMPLAINT OF ABDOMINAL PAIN. X-RAY REVEALED AIR BELOW THE DIAPHRAGM. THE PT UNDERWENT LAPAROSCOPY FOLLOWED BY LAPAROTOMY. NOTED FINDINGS INCLUDE A 2-3 CM BLANCHED AREA AT THE FUNDUS, WITHOUT EVIDENCE OF PERFORATION, THERMAL INJURY TO THE CAECUM AND PERFORATION OF THE SMALL BOWEL FOR WHICH RESECTION WAS PERFORMED AND, ANASTOMOSIS.

    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. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization