BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    MDR report key: 1629678 · Received March 8, 2010

    Report

    Report Number
    9710493-2010-00002
    Event Type
    Injury
    Date Received
    March 8, 2010
    Date of Event
    July 22, 2009
    Report Date
    March 5, 2010
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MFR DATE: SYST. 05/2003. 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. THE APPLICATOR IS NOW IN USE AT ANOTHER FACILITY. RETURN OF THE APPLICATOR HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PT WAS TREATED WITH A REUSABLE MEA APPLICATOR. THE PT RETURNED TWO DAYS POST MEA WITH COMPLAINT OF ABDOMINAL PAIN. INVESTIGATIVE SURGERY REVEALED UTERINE PERFORATION AND THERMAL INJURY TO THE BOWEL. BOWEL RESECTION WAS PERFORMED. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    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