BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1324952 · Received February 25, 2009

    Report

    Report Number
    3005099803-2008-02868
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    May 24, 2007
    Report Date
    May 24, 2007
    Manufacturer
    NORTH AMERICAN STERILIZATION AND PACKAGING CO.
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS REPORTED FOR MINOR CERVICAL BURN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION COULD NOT BE PERFORMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW (DHR) COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2007 THAT A HYDROTHERMABLATOR PROCEDURE SET WAS USED DURING A ENDOMETRIAL ABLATION PROCEDURE PERFORMED IN 2007 (FEMALE PATIENT; AGE AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, A FLUID LEAK RESULTED IN THE PATIENT'S CERVIX BEING BURNED. ACCORDING TO THE REP AND WHO WAS PRESENT DURING THE CASE, THE DOCTOR WAS USING THE TENACULUM STABILIZER DURING THIS EVENT. THE DOCTOR STATED THAT SHE NOTICED AT THE SEVEN MINUTE MARK FLUID STARTED TO LEAK. SHE IMMEDIATELY ABORTED THE PROCEDURE. SHE BELIEVES IT WAS ONLY A 5CC LOSS (NOT SURE). THE DOCTOR LOOKED AT THE PATIENT'S CAVITY AND ONLY SAW SOME FLUFFING. THEY RESTARTED THE CASE, THE DOCTOR REPOSITIONED THE TENCAULUM STABILIZER AND CONTINUED THE CASE. IT WAS COMPLETED AND THOUGHT TO BE SUCCESSFUL. UPON POST EXAMINATION IT APPEARS THAT A SMALL BURN IS LOCATED ON THE PATIENT'S CERVIX. IT WAS INDICATED THAT THE PATIENT SUFFERED A FIRST DEGREE BURN AND IT WAS TREATED WITH SILVADENE CREAM. A FULL RECOVERY IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB MNB NORTH AMERICAN STERILIZATION AND PACKAGING CO. M006560201 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other