BEUDAMED
    FDA Adverse Event Death Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 2029147 · Received March 14, 2011

    Report

    Report Number
    2210968-2011-00247
    Event Type
    Death
    Date Received
    March 14, 2011
    Date of Event
    June 1, 2010
    Report Date
    February 9, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/11/2011. (B)(4). CONCLUSIONS: 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 LAPAROSCOPIC SPLENECTOMY PROCEDURE ON (B)(6) 2010. DURING THE PROCEDURE, THE SPLEEN HAD BEEN MOVED INTO AN ENDO BAG. THE MORCELLATOR WAS USED INSIDE THE ENDO BAG. THE REPORTER, WHO IS AN ATTORNEY, SUSPECTS THAT THE SURGEON COULD NOT VISUALIZE WHAT HE WAS DOING AND HIT THE AORTA. THE PT DIED APPROXIMATELY TWO WEEKS LATER AS A RESULT OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE X-TRACT MORCELLATOR MORCELLATOR HET ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| L| R