BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-LIX TISSUE GRASPER

    MDR report key: 1353753 · Received March 30, 2009

    Report

    Report Number
    3004447686-2009-00001
    Event Type
    Injury
    Date Received
    March 30, 2009
    Date of Event
    March 3, 2009
    Report Date
    March 30, 2009
    Manufacturer
    USGI MEDICAL
    Product Code
    HET
    PMA / PMN Number
    K061268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN REPORTS THAT SURGICAL PROCEDURE PERFORMED 2 WEEKS PRIOR TO THIS EVENT WAS SUCCESSFUL AND INSPECTION OF THE OPERATIVE SITE AT THE CONCLUSION OF THAT PROCEDURE SHOWED NO REMARKABLE FINDINGS. PHYSICIAN SUSPECTS THAT MANIPULATION OF GASTRIC TISSUE WITH THE GRASPER MAY HAVE CAUSED SOME INCIDENTAL TRAUMA TO THE LIVER AND SUBSEQUENT LIVER HEMATOMA.

    Description of Event or Problem · 1

    PT ADMITTED TO HOSP FOR OBSERVATION AND TESTS IN 2009 WITH ABDOMINAL PAIN, FEVER AND CHILLS TWO WEEKS POST ENDOLUMENAL PROCEDURE TO REDUCE DILATED GASTROJEJUNAL ANASTOMOSIS. PT HAD ELEVATED WBC, ANEMIA, FEVER AND CT SHOWED LEFT LOBE LIVER HEMATOMA. PT RECEIVED IV FLUIDS, ANTIBIOTICS, AND ANALGESICS AND TWO UNITS OF BLOOD. PT DISCHARGED FOUR DAYS LATER, WITH NORMAL BLOOD WORK, NO FEVER AND NO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G-LIX TISSUE GRASPER TISSUE GRASPER HET USGI MEDICAL PME080409

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization