BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    MDR report key: 1163066 · Received September 15, 2008

    Report

    Report Number
    9710493-2008-00007
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 11, 2008
    Report Date
    September 12, 2008
    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

    ADD'L DEVICE MFR DATE: APPL. 07/2004. 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.

    Description of Event or Problem · 1

    PT HAD AN UNEVENTFUL MEA PROCEDURE WITH A REUSABLE APPLICATOR. PT RETURNED 1 DAY POST MEA WITH COMPLAINT OF ABDOMINAL PAIN. HYSTERECTOMY AND BOWEL RESECTION PERFORMED TO CORRECT THERMAL INJURY.

    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 UNK Required Intervention