BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1822829 · Received August 30, 2010

    Report

    Report Number
    2210968-2010-01007
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    August 24, 2009
    Report Date
    August 13, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THERE WERE NO VISUAL DEFECTS FOUND. A LEAK TEST WAS NOT ABLE TO BE PERFORMED DUE TO A CRACKED LUER FITTIG. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-01006. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B)(6) 2009. THE CATHETER PRIMED FINE BUT THREE MINUTES AFTER THE PROCEDURE START TIME THE PRESSURES ON THE GENERATOR STARTED FLUCTUATING AND AN ERROR CODE FLASHED SAYING "OVERHEATER ERROR". THE SURGEON SWITCHED OFF THE MACHINE AND QUIT THE PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PERSONAL INJURIES, PERSISTENT VAGINAL BLEEDING, AND CHRONIC FATIGUE. THE PATIENT DEVELOPED ABDOMINAL CRAMPS AND DIARRHEA AND WAS TREATED ON (B)(6) 2009 BY HER PHYSICIAN. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. NA BAMG03

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention