BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 726615 · Received June 16, 2006

    Report

    Report Number
    2210968-2006-00431
    Event Type
    Injury
    Date Received
    June 16, 2006
    Date of Event
    April 1, 2006
    Report Date
    May 17, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K963872
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE FAILURE REPORTED. THE EVENT REPORTED WAS THE RESULT OF SURGICAL TECHNIQUE. 510(K) # IS K963872

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A LAPARASCOPIC SUPRACERVICAL HYSTERECTOMY IN 2006. DURING MORCELLATION, THE PHYSICIAN WAS OPERATING THE TROCAR AND PULLING TISSUE INTO THE MORCELLATOR. HE REPORTS THAT SECONDARY TO HIS INCISION SIZE, THE TROCAR TRENDED TO REPEATEDLY SLIP DEEPER INTO THE ABDOMEN. AT ONE POINT, THIS OCCURRED AND THE ACTIVE BLADE INJURED THE RIGHT URETER, RIGHT SIDE WALL BLOOD VESSELS, AND BOWEL. THE PATIENT SUBSEQUENTLY UNDERWENT COLOSTOMY WHICH CURRENTLY IS FUNCTIONING WELL AND WILL BE TAKEN DOWN 2006. THE RIGHT URETER WAS REPAIRED WITH STENT PLACEMENT WHICH HAS SINCE BEEN REMOVED. TRANSFUSION WITH SIX UNITS OF PACKED RED BLOOD CELLS AND TWO UNITS OF FRESH FROZEN PLASMA WAS REQUIRED. THE PATIENT IS CURRENTLY DOING WELL. THE SURGEON REPORTS THAT THERE WAS NO DEVICE MALFUNCTION.

    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 42 YR Life Threatening| R