BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 3921409 · Received July 9, 2014

    Report

    Report Number
    3005099803-2014-02505
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2014-02504 PERTAINS TO THE GENESYS HYDROTHERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM AND MANUFACTURER REPORT # 3005099803-2014-02505 PERTAINS TO THE GENESYS HYDROTHERMABLATION PROCERVA PROCEDURE SET. 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) 2014. ACCORDING TO THE COMPLAINANT, DURING THE ABLATION PHASE, THE PHYSICIAN NOTED SIGNIFICANT AMOUNT OF SALINE POOLING IN THE VAGINAL CANAL AND SOME FLUID LEAKING OUT OF THE CERVIX. THE PUDDLE OF FLUID WAS MORE THAN APPROXIMATELY 100CC. HOWEVER, THE MACHINE DID NOT GIVE OFF AN ALARM TO INDICATE THE FLUID LOSS. ADDITIONALLY, IT WAS REPORTED THAT A RAYTEC SPONGE WAS USED TO WIPE THE VAGINAL VAULT PRIOR TO ABLATION. A TENACULUM WAS USED TO OBTAIN CERVICAL SEAL AND THE SHEATH WAS NOT EXCESSIVELY MOVED THAT COULD HAVE CAUSED THE LEAKING. SALINE TEMPERATURE WAS 80 DEGREES CELSIUS WHEN THE LEAK WAS DISCOVERED, AND THE MACHINE WAS IMMEDIATELY PAUSED THEN SHUT DOWN TO PREVENT FURTHER HEATING. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "OKAY." TWO DAYS FOLLOWING THE PROCEDURE, THE PHYSICIAN EXAMINED THE PATIENT AND NO SIGNS OF BURNS AND TISSUE INJURY NOR ANY REDNESS OR PAIN WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400995 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - SPENCER M006580210 16672966

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR