BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    MDR report key: 615224 · Received June 16, 2005

    Report

    Report Number
    9710493-2005-00003
    Event Type
    Injury
    Date Received
    June 16, 2005
    Date of Event
    May 12, 2005
    Report Date
    June 16, 2005
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MEA PROCEDURE PERFORMED IN 2005 IN A UTERINE CAVITY CONFIRMED TO BE 9CM IN LENGTH. DURING FUNDAL TREATMENT A 3 TO 4CM FORWARD ADVANCEMENT OF THE MEA APPLICATOR WAS DISCOVERED BY PHYSICIAN. APPLICATOR WAS PULLED BACK TO AN UNK POSITION, AND TREATMENT CONTINUED TO A TOTAL TREATMENT TIME OF 185 SECONDS AT WHICH POINT PHYSICIAN DECIDED TO DISCONTINUE TREATMENT. PT PRESENTED TO THE HOSP TWO DAYS POST-TREATMENT WITH ACUTE ABDOMINAL PAIN. LAPAROTOPY WAS PERFORMED, REVEALING UTERINE PERFORATION IN MID-FUNDAL POSITION; INJURY TO SMALL BOWEL WAS NOTED; BOWEL SURGERY WAS PERFORMED.

    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 UNKNOWN Hospitalization| R