BEUDAMED
    FDA Adverse Event Death Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 2063458 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00442
    Event Type
    Death
    Date Received
    April 19, 2011
    Date of Event
    February 13, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ETHICON
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 A PATIENT UNDERWENT A ROBOTICALLY ASSISTED HYSTERECTOMY ON (B)(6) 2009 TO CONTROL HER SYMPTOMATIC FIBROIDS. DURING MORCELLATION OF THE UTERUS, AT ONE POINT THE DEVICE DID NOT FUNCTION PROPERLY. IN ADDITION, THE CAMERA DID NOT FUNCTION PROPERLY AND HAD TO BE RE-CABLED AND RE-SET. THE PATIENT WAS TRANSFERRED FROM THE OPERATING ROOM. THREE DAYS POST-OPERATIVE, THE PATIENT DEVELOPED A FEVER, SHORTNESS OF BREATH, AND TACHYCARDIA. BY POST-OPERATIVE DAY FIVE, THE PATIENT WAS NOTED TO HAVE FECAL MATERIAL EMANATING FROM A RIGHT LOWER QUADRANT PORT AND WAS RETURNED TO THE OPERATING ROOM. IT WAS DISCOVERED THAT SHE HAD A CECAL INJURY AND THE DEVELOPMENT OF NECROTIZING FASCIITIS. SHE UNDERWENT A CECAL REANASTOMOSIS AND DEBRIDEMENT OF THE AFFECTED TISSUE. THE PATIENT REQUIRED LONG TERM VENTILATOR SUPPORT AND TPN FEEDINGS, ALONG WITH THE PLACEMENT OF A G-J TUBE. SHE WAS TRANSFERRED TO A LONG TERM ACUTE FACILITY ON (B)(6) 2009. THE PATIENT DIED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE X-TRACT MORCELLATOR MORCELLATOR HET ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death| L| R