BEUDAMED
    FDA Adverse Event Death Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1739214 · Received June 25, 2010

    Report

    Report Number
    2210968-2010-00728
    Event Type
    Death
    Date Received
    June 25, 2010
    Date of Event
    May 28, 2010
    Report Date
    May 28, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE INFO FOR USE STATES "TO PREVENT ACCIDENTAL INJURIES TO THE ABDOMINAL WALL OR SIMILAR STRUCTURE, THE TISSUE TO BE MORCELLATED SHOULD BE COMPLETELY EXPOSED BEFORE APPLYING THE DEVICE. IN ADDITION, IT IS RECOMMENDED THAT A SECOND PAIR OF GRASPING FORCEPS OR A FIXATION INSTRUMENT BE USED TO PREVENT LARGE PIECES OF TISSUE FROM UNCONTROLLABLY MOVING. SLIPPAGE OF THE CUTTING TUBE CAN CAUSE SIGNIFICANT INJURY".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A LAPAROSCOPIC PARTIAL NEPHRECTOMY PROCEDURE ON (B) (6) 2010. DURING THE PROCEDURE, AFTER THE KIDNEY WAS REMOVED AND SECURED IN THE ENDO POUCH, THE SURGEON STARTED TO MORCELLATE THE KIDNEY OUT OF THE POUCH. AFTER MORCELLATING THE SECOND BIT OF TISSUE OUT, THE SURGEON ABORTED MORCELLATION AND CONFIRMED THAT THE POUCH WAS TORN. THE SURGEON SAW MINOR BLEEDING. THE BLOOD WAS SURFACING SLOWLY WHICH WAS THEN IRRIGATED AND SUCTIONED. AFTER APPROXIMATELY TEN MINUTES, THE PT'S BLOOD PRESSURE AND HEART RATE DROPPED AND THE SURGERY WAS CONVERTED TO AN OPEN PROCEDURE. A GENERAL SURGEON FOUND THAT THE ILIAC ARTERY HAD BEEN PERFORATED AND PERFORMED AN ANASTOMOSIS OF THE ARTERY WITH A GRAFT AND REPAIRED THE PERFORATION. THE PT WAS STABILIZED AND TAKEN TO THE ICU. THE PT EXPIRED THE NEXT MORNING. THE EXACT CAUSE OF DEATH IS UNK. ADD'L INFO HAS BEEN REQUESTED.

    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 UNK Death ENDOPOUCH FROM COVIDIEN