BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1610614 · Received February 8, 2010

    Report

    Report Number
    2210968-2010-00109
    Event Type
    Injury
    Date Received
    February 8, 2010
    Date of Event
    November 23, 2009
    Report Date
    December 5, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE AND A DILATION AND CURETTAGE PROCEDURE ON (B) (6) 2009. DURING THE PROCEDURE, THE ENDOMETRIAL PRESSURE WAS LOST AT THREE MINUTES INTO THE THERAPY CYCLE AND THE PROCEDURE WAS ABORTED. ON (B) (6) 2009, THE PATIENT EXPERIENCED SUDDEN ONSET OF PAIN AND PRESENTED TO THE EMERGENCY ROOM ON (B) (6) 2009. ON (B) (6) 2009, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR EXPLORATORY LAPAROSCOPIC SURGERY AND WAS FOUND TO HAVE A BOWEL BURN WITH PERFORATION AND SEPSIS, AND UNDERWENT A BOWEL RESECTION AND COLOSTOMY PROCEDURE. THE SURGEON OPINES THAT THE PATIENT'S UTERUS WAS THIN DURING THE ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B) (6) 2009. THEREFORE, THE UTERUS WAS BURNED WHICH CAUSED A UTERINE PERFORATION AND THE BOWEL SUSTAINED THERMAL DAMAGE. THE PATIENT WAS GIVEN ANTIBIOTICS AND PAIN MEDICATIONS AND SHE WAS HOSPITALIZED FOR TEN DAYS. ON (B) (6) 2009, THE PATIENT'S CONDITION WAS STABLE. ON (B) (6) 2009, THE PATIENT WAS STILL EXPERIENCING ABNORMAL UTERINE BLEEDING AND THE UTERINE PERFORATION WAS HEALED. A COLOSTOMY REVERSAL IS PLANNED IN SIX MONTHS.

    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 45 YR Hospitalization| L| R