BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    MDR report key: 1408167 · Received June 25, 2009

    Report

    Report Number
    9710493-2009-00003
    Event Type
    Other
    Date Received
    June 25, 2009
    Date of Event
    May 25, 2009
    Report Date
    June 26, 2009
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    PATIENT WAS TREATED WITH A REUSABLE MEA APPLICATOR. MEA PROCEDURE ABORTED DUE TO SUSPECTED FORWARD ADVANCEMENT OF THE APPLICATOR. LAPAROSCOPY FOR STERILIZATION WAS BEING CONDUCTED AT THE SAME TIME AS THE MEA PROCEDURE, CONFIRMED A UTERINE PERFORATION AND AN APPROXIMATE 1 CM BLANCHED AREA ON THE SIGMOID COLON. THE PATIENT WAS ADMITTED FOR OBSERVATION ONLY. THE PATIENT RECOVERED WITHOUT FURTHER SEQUELAE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization