BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1592792 · Received January 28, 2010

    Report

    Report Number
    2210968-2010-00096
    Event Type
    Injury
    Date Received
    January 28, 2010
    Report Date
    December 29, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A DILATION AND CURETTAGE, HYSTEROSCOPY, AND AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON AN UNK DATE. THE UTERUS SOUNDED TO 7.5CM AND WAS MIDLINE TO ANTEVERTED. DURING THE PROCEDURE, THE PRESSURE WAS STABILIZED AT 160MMHG WITH 20CC OF D5W INJECTED, AND THE DOCTOR STARTED THE PREHEAT CYCLE FOLLOWED BY THE THERAPY CYCLE WHEN, AFTER TWO AND A HALF MINUTES OF THERAPY, THE PRESSURE STARTED SLOWLY DROPPING. THE DOCTOR ADDED 2 TO 5CC TO THE BALLOON AND THE PRESSURE ROSE FOR A FEW SECONDS THEN STARTED DROPPING MORE QUICKLY. THE DOCTOR STOPPED THE CASE AT THAT POINT, PERFORMED A DIAGNOSTIC HYSTEROSCOPY AND NOTICED A PERFORATION IN THE WALL OF THE UTERUS. ADDITIONAL INFO HAS BEEN REQUESTED.

    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