BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2001476 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00612
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE PRODUCT WAS RECEIVED IN GOOD CONDITION. THE UNIT PASSED THE GENESYS HTA FUNCTIONAL FEATURE TEST, AND NO POWER RELATED ISSUES OR ERROR MESSAGES WERE OBSERVED DURING THE TEST. ADDITIONALLY, NO VISUAL DEFECTS OR LOOSE CONNECTIONS WERE OBSERVED AFTER DISASSEMBLING THE CONSOLE. THE CONSOLE RAN OVERNIGHT (CONTINUOUS OPERATION) FOR 13 HOURS WITHOUT FAILURE. NO ERROR MESSAGES OR FAULTS WERE RECORDED INTO THE SYSTEM MEMORY DURING 2 DATA SETS THAT WERE RECORDED FROM THE EVENT DATE PROVIDED. THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS "NOT CONFIRMED."

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BUT AN EVALUATION HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM WAS USED IN A HYDRO THERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6), 2011 (PATIENT ID, AGE, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE CONSOLE DISPLAY APPEARED TO "FLASH," FROM INTERMITTENT POWER APPROXIMATELY ONE MINUTE INTO THE ABLATION, AND THE CONSOLE SHUTDOWN. NO ALARMS OR ERROR CODES WERE GENERATED PRIOR TO THE SHUT DOWN. WHEN THE SYSTEM CAME BACK UP IT SHOWED AN ERROR MESSAGE AND PROCEEDED TO PATIENT COOL DOWN. THE TEMPERATURE OF THE SALINE AT THE TIME THE SYSTEM SHUT DOWN IS UNKNOWN, HOWEVER IT WAS CONFIRMED THAT FLUID WAS INSIDE THE CAVITY AT THE TIME. THE POWER CABLE WAS ALSO CONFIRMED TO BE CONNECTED PROPERLY. THE PROCEDURE SET WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE 'FINE.'

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM WAS USED IN A HYDRO THERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6), 2011 (PATIENT ID, AGE, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE CONSOLE DISPLAY APPEARED TO "FLASH," FROM INTERMITTENT POWER APPROXIMATELY ONE MINUTE INTO THE ABLATION, AND THE CONSOLE SHUTDOWN. NO ALARMS OR ERROR CODES WERE GENERATED PRIOR TO THE SHUT DOWN. WHEN THE SYSTEM CAME BACK UP IT SHOWED AN ERROR MESSAGE AND PROCEEDED TO PATIENT COOL DOWN. THE TEMPERATURE OF THE SALINE AT THE TIME THE SYSTEM SHUT DOWN IS UNKNOWN, HOWEVER IT WAS CONFIRMED THAT FLUID WAS INSIDE THE CAVITY AT THE TIME. THE POWER CABLE WAS ALSO CONFIRMED TO BE CONNECTED PROPERLY. THE PROCEDURE SET WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    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

    Patients

    Seq Age Sex Outcome Treatment
    1