BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    MDR report key: 822635 · Received March 1, 2007

    Report

    Report Number
    9710493-2007-00001
    Event Type
    Injury
    Date Received
    March 1, 2007
    Date of Event
    May 22, 2006
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS APPLICATOR WAS NOT RETURNED TO MICROSULIS AT THE TIME OF THE INCIDENT, HOWEVER, IT WAS RETURNED MONTHS LATER IN NOVEMBER 2006 WHEN MICROSULIS WAS CONVERTING THIS USER SITE FROM THE REUSABLE APPLICATOR TO THE SINGLE-USE FEMWAVE APPLICATOR. DURING NORMAL REFURBISHMENT PROCEDURES, THE RETURNED APPLICATOR SHOWED SIGNS OF WATER INGRESS AT THE APPLICATOR TIP, A TIGHT DATA CONNECTOR COVER, AND THAT THERMOCOUPLE 2 (TC2) WAS NOT WORKING. THE DATA LOGGED IN FOR THE MEA TREATMENT IN THIS REPORT PROVIDES DOCUMENTATION OF SYSTEM PERFORMANCE PARAMETERS DURING TREATMENT. THIS RECORD INDICATES THAT THE MEA SYSTEM OPERATED WITHIN THE REQUIRED TOLERANCE DURING THE TREATMENT. THE RECORD ALSO INDICATES THAT THE APPLICATOR WAS OPERATIONAL DURING THIS TREATMENT. IF WATER INGRESS WAS PRESENT DURING THE TREATMENT THEN REFLECTED POWER WOULD BE HIGH. FURTHERMORE, IF TC2 WAS NOT OPERATIONAL THEN THE MEA SYSTEM WOULD NOT ALLOW FOR A TREATMENT TO START. THE TEMPERATURE PROFILE CLEARLY SHOWS LOW REFLECTED POWER AND A FUNCTIONAL TC2. MICROSULIS IS AWARE THAT THIS EVENT SHOULD HAVE BEEN REPORTED EARLIER. A CORRECTIVE/PREVENTIVE ACTION PLAN HAS BEEN OPENED TO PREVENT ANY FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    MEA WITH REUSABLE APPLICATOR PERFORMED WITHOUT OBSERVED COMPLICATIONS. PATIENT COMPLAINED OF ABDOMINAL PAIN ONE DAY POST MEA. LAPAROTOMY DIAGNOSED A FUNDAL UTERINE PERFORATION AND THERMAL INJURY TO THE SIGMOID COLON. THE AFFECTED AREA ON THE SIGMOID COLON WAS OVERSEWN. CAUSE OF PERFORATION UNKNOWN.

    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 YR Required Intervention