BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1324858 · Received February 25, 2009

    Report

    Report Number
    3005099803-2008-02586
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    May 18, 2007
    Report Date
    May 18, 2007
    Manufacturer
    NORTH AMERICAN STERILIZATION AND PACKAGING CO.
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS REPORTED FOR LOSS OF FLUID. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION COULD NOT BE PERFORMED, AND 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 ON THAT A HYDROTHERMABLATOR PROCEDURE SET WAS USED DURING A ENDOMETRIAL ABLATION PROCEDURE PERFORMED IN 2007 (FEMALE PATIENT; AGE AND WEIGHT ARE UNKNOWN). DURING PREPARATION, THERE WAS A FLUID LOSS OF 10 CC AT A RATE OF 7 CC A MINUTE. THE PHYSICIAN CHECKED THE CERVICAL SEAL AND SAW NOTHING. EVERYTHING LOOKED GOOD AND CONTINUED WITH THAT PHASE OF THE PROCEDURE. APPROXIMATELY, HALF WAY THROUGH THE PROCEDURE, THE PHYSICIAN HAD ANOTHER 10 CC FLUID LOSS OF ABOUT 4 CC A MINUTE. THE PHYSICIAN CHECKED THE CERVICAL SEAL AGAIN AND DECIDED TO CONTINUE. ABOUT 10 SECONDS BEFORE COMPLETION OF THE PROCEDURE ANOTHER 10 CC FLUID LOSS AT ABOUT 3 CC A MINUTE. THE PHYSICIAN ABORTED THE PROCEDURE, BUT IT WAS CONSIDERED FINISHED BY THE PHYSICIAN. THE DOCTOR DECIDED TO PERFORMED A LAPAROSCOPY AND NOTICED FLUID OUTSIDE HER CAVITY BUT NO TRACE OF ANY BURNS AT ALL. THE PATIENT WAS KEPT OVERNIGHT JUST FOR OBSERVATION ONLY. THIS WAS BECAUSE THERE WAS TWO DOCTORS THAT PERFORMED THE CASE, AND IT WAS THE FIRST TIME FOR ONE OF THEM. IT WAS ALSO NOTED THAT THE PATIENT HAS A LOW TOLERANCE FOR PAIN AND WAS COMPLAINING ABOUT SOME PAIN. THE PATIENT WAS RELEASED WITH NO ISSUES.

    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