BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1063121 · Received June 20, 2008

    Report

    Report Number
    2210968-2008-00433
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A DILATATION AND CURETTAGE, HYSTEROSCOPY, THERMAL ENDOMETRIAL ABLATION, AND THEN A SECOND HYSTEROSCOPY. THERE WERE NO NOTED PROBLEMS DURING THE PROCEDURES. THE PATIENT PRESENTED TWO WEEKS AFTER THE PROCEDURE, ONE WEEK LATE FOR HER POST-OPERATIVE APPOINTMENT, AND WAS FOUND TO HAVE A CERVICAL BURN WHICH ALSO COVERED HER LOWER UTERINE SEGMENT. THE CERVIX APPEARED "LIKE IT WAS TORN". THE PATIENT'S UTERUS WAS REPORTED TO BE TILTED AND THE SURGEON OPINES THAT DURING THE PROCEDURE, WHEN HE THOUGHT HE WAS AT THE FUNDUS, HE WAS ACTUALLY STILL IN THE CERVIX. AN EMERGENCY HYSTERECTOMY WAS PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention