BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 3181497 · Received June 21, 2013

    Report

    Report Number
    3005099803-2013-05115
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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) 2013. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS SET UP AS USUAL. HOWEVER, THE SYSTEM WAS PAUSED DURING DIAGNOSTIC HYSTEROSCOPY WHEN THE PHYSICIAN NOTED A CERVICAL LEAK. THE BUTTON WAS PRESSED TO CONTINUE AND THE SYSTEM WENT INTO ABLATION PHASE. THEY WERE UNABLE TO GO BACK TO DIAGNOSTIC HYSTEROSCOPY. THE PROCEDURE WAS CANCELLED AND A DIFFERENT PROCEDURE WAS PERFORMED. THE PATIENT WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283306 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - FREMONT (CE) M006580211

    Patients

    Seq Age Sex Outcome Treatment
    1