BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    MDR report key: 881634 · Received April 7, 2007

    Report

    Report Number
    9710493-2007-00009
    Event Type
    Other
    Date Received
    April 7, 2007
    Date of Event
    December 21, 2006
    Report Date
    July 17, 2007
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE APPLICATOR WAS DISPOSED OF BY THE USER AND THUS COULD NOT BE ANALYZED.

    Description of Event or Problem · 1

    PATIENT WAS TREATED WITH A SINGLE USE FEMWAVE APPLICATOR. USER FACILITY REPORTED UTERINE PERFORATION, REQUIRING HYSTERECTOMY. THE COMPANY HAS BEEN UNABLE TO CONFIRM WITH THE SURGEON THE INDICATION FOR THE HYSTERECTOMY.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization