BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2240780 · Received September 9, 2011

    Report

    Report Number
    3005099803-2011-03012
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE RETURNED UNIT FAILED THE GENESYS HTA FUNCTIONAL FEATURE TEST. A WINDOWS "BLUE SCREEN" ERROR "PAGE FAULT" WAS OBSERVED, AND NO AUDIBLE TONE WAS HEARD. ADDITIONAL TESTING WAS PERFORMED DURING THE COMPLAINT INVESTIGATION FOR THIS UNIT. THE UNIT WAS POWERED UP AND LEFT ON FOR SEVERAL HOURS; NO ERROR MESSAGES WERE OBSERVED. ALTHOUGH THE REPORTED PROBLEM WAS NOT DUPLICATED UNDER TEST CONDITIONS, RELATED FAILURES OCCURRED DURING THE FUNCTIONAL TESTING OF THE UNIT. BOTH THE REPORTED PROBLEM AND THE OBSERVED PROBLEMS ARE RELATED ERRORS PERTAINING TO THE INTERNAL LOGIC BOARD IN THE FRONT ENCLOSURE ASSEMBLY. THEREFORE, THE REPORTED PROBLEM WAS CONFIRMED, AND THE PROBABLE ROOT CAUSE OF THE FAILURES IS A DEFECTIVE LOGIC BOARD IN THE FRONT ENCLOSURE ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDROTHERMABLATION CONTROL UNIT WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON AN UNKNOWN PROCEDURE DATE. ACCORDING TO THE COMPLAINANT, THE GENESYS HYDROTHERMABLATION CONTROL UNIT HAD COMPLETELY "FROZE UP" ON AT LEAST TWO OCCASIONS. THERE WERE APPARENTLY NO ERROR MESSAGES DISPLAYED. THE FIRST INCIDENT OCCURRED DURING COOL DOWN. THE SECOND INCIDENT OCCURRED DURING SYSTEM INITIALIZATION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE CURRENT CONDITION OF THE PATIENT IS CURRENTLY UNKNOWN AS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDROTHERMABLATION CONTROL UNIT WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON AN UNKNOWN PROCEDURE DATE. ACCORDING TO THE COMPLAINANT, THE GENESYS HYDROTHERMABLATION CONTROL UNIT HAD COMPLETELY "FROZE UP" ON AT LEAST TWO OCCASIONS. THERE WERE APPARENTLY NO ERROR MESSAGES DISPLAYED. THE FIRST INCIDENT OCCURRED DURING COOL DOWN. THE SECOND INCIDENT OCCURRED DURING SYSTEM INITIALIZATION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE CURRENT CONDITION OF THE PATIENT IS CURRENTLY UNKNOWN AS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - FREMONT M006580010 GEN0224

    Patients

    Seq Age Sex Outcome Treatment
    1