BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    MDR report key: 1729855 · Received June 16, 2010

    Report

    Report Number
    9710493-2010-00004
    Event Type
    Injury
    Date Received
    June 16, 2010
    Date of Event
    April 6, 2010
    Report Date
    June 14, 2010
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE MANUFACTURE DATE: APPL. 08/2005. 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 WAS TREATED WITH A REUSABLE MEA APPLICATOR. THE PT RETURNED 5 DAYS POST MEA WITH COMPLAINT OF ABDOMINAL PAIN, WITH A DIAGNOSIS OF ENDOMETRITIS. INVESTIGATIVE SURGERY REVEALED A SMALL AREA OF BOWEL ADHERED TO THE UTERUS WHICH WAS SUBSEQUENTLY SEPARATED AND OVERSTITCH OF THE UTERUS PERFORMED. NO EVIDENCE OF UTERINE PERFORATION OR BLANCHING NOTED. PT HAD A SATISFACTORY RECOVERY.

    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 Hospitalization