BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 3121935 · Received May 21, 2013

    Report

    Report Number
    3005099803-2013-03789
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DISPOSED OF AND IS NOT AVAILABLE FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS EXAMINED BY THE PHYSICIAN ON (B)(6) 2013. THE PHYSICIAN REPORTED THE BURN APPEARS TO BE HEALED, THOUGH THE PATIENT CONTINUES TO COMPLAIN OF DYSPAREUNIA.

    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 UNDER GENERAL ANESTHESIA ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PATIENT RECEIVED A 2ND DEGREE BURN TO HER VAGINA, INTROITUS, AND LEFT BUTTOCK. THE VAGINAL BURNS APPEAR TO BE LOCATED BILATERAL, IN WHAT APPEARS TO BE TWO LINES WHERE THE SPECULUM WOULD BE OPEN. ADDITIONALLY, THE BURN TO THE BUTTOCK IS LOCATED WHERE THE SPECULUM WOULD TOUCH THE SKIN. THE PHYSICIAN REPORTEDLY USED TWO TENACULUM. THERE WERE NO FLUID LOSS ALARMS OR DEFICITS REGISTERED DURING ANY PHASE OF THE PROCEDURE. HOWEVER, AT THE END OF THE COOLING CYCLE AN INSUFFICIENT PATIENT COOLING MESSAGE OCCURRED. A SECOND COOLING CYCLE WAS COMPLETED. SYLVADENE CREAM WAS APPLIED TO THE BURN AREAS AND THE PATIENT WAS PRESCRIBED THE CREAM FOR USE "UNTIL HEALED". THE PATIENT WAS SCHEDULED FOR FOLLOW UP. AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN WAS UNSUCCESSFUL. THE PATIENT WAS REPORTED TO BE DOING "FINE".

    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 UNDER GENERAL ANESTHESIA ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PATIENT RECEIVED A 2ND DEGREE BURN TO HER VAGINA, INTROITUS, AND LEFT BUTTOCK. THE VAGINAL BURNS APPEAR TO BE LOCATED BILATERAL, IN WHAT APPEARS TO BE TWO LINES WHERE THE SPECULUM WOULD BE OPEN. ADDITIONALLY, THE BURN TO THE BUTTOCK IS LOCATED WHERE THE SPECULUM WOULD TOUCH THE SKIN. THE PHYSICIAN REPORTEDLY USED TWO TENACULUM. THERE WERE NO FLUID LOSS ALARMS OR DEFICITS REGISTERED DURING ANY PHASE OF THE PROCEDURE. HOWEVER, AT THE END OF THE COOLING CYCLE AN INSUFFICIENT PATIENT COOLING MESSAGE OCCURRED. A SECOND COOLING CYCLE WAS COMPLETED. SILVADENE CREAM WAS APPLIED TO THE BURN AREAS AND THE PATIENT WAS PRESCRIBED THE CREAM FOR USE "UNTIL HEALED." THE PATIENT WAS SCHEDULED FOR FOLLOW UP. AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN WAS UNSUCCESSFUL. THE PATIENT WAS REPORTED TO BE DOING "FINE." THE PATIENT WAS EXAMINED BY THE PHYSICIAN ON JUNE 5, 2013. THE PHYSICIAN REPORTED THE BURN APPEARS TO BE HEALED, THOUGH THE PATIENT CONTINUES TO COMPLAIN OF DYSPAREUNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224905 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006580211

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention