BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA?

    MDR report key: 3915543 · Received July 7, 2014

    Report

    Report Number
    3005099803-2014-02444
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS UNDER GENERAL ANESTHESIA. THREE MINUTES INTO ABLATION, THE PATIENT STARTED TO WAKE UP AND MOVE. A FLUID LOSS ALARM WITH A RATE OF 127 ML/MIN WAS THEN DISPLAYED. THE PHYSICIAN NOTED A CERVICAL LEAK AND ABORTED THE PROCEDURE. THE PATIENT SUSTAINED BURN INJURY INVOLVING THE VAGINA, CERVIX AND PERINEUM, AND WAS TREATED WITH SILVADENE CREAM. PAIN MEDICATION WAS ALSO PRESCRIBED. ON (B)(6) 2014, THE PHYSICIAN EXAMINED THE PATIENT AND CLASSIFIED THE BURNS AS THIRD DEGREE ON THE VAGINA AND CERVIX, AND SECOND DEGREE ON THE PERINEUM. CURRENTLY, THE PATIENT IS STILL ON PAIN MEDICATION AND BURN CREAM, AND IS REPORTED TO BE RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394044 GENESYS HTA PROCERVA? DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - SPENCER UNK675

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other