BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    MDR report key: 2240649 · Received December 11, 2007

    Report

    Report Number
    9710493-2007-00014
    Event Type
    Other
    Date Received
    December 11, 2007
    Date of Event
    October 29, 2007
    Report Date
    December 4, 2007
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO - SYS. 10/2000. 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 SPECS AT THE TIME OF THE TREATMENT, AND NO MALFUNCTIONS OR PERFORMANCE DEVIATIONS WERE PRESENT.

    Description of Event or Problem · 1

    PT WAS TREATED WITH A REUSABLE APPLICATOR. USER RECOGNIZED FORWARD ADVANCEMENT OF THE APPLICATOR AND ABORTED THE TREATMENT. LAPAROSCOPY CONFIRMED UTERINE PERFORATION WITHOUT OTHER INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other