BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-LIX TISSUE GRASPER

    MDR report key: 2231079 · Received August 26, 2011

    Report

    Report Number
    3004447686-2011-00002
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 26, 2011
    Manufacturer
    USGI MEDICAL
    Product Code
    HET
    PMA / PMN Number
    K061268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR DID NOT EXPERIENCE ANY MALFUNCTIONS WITH THE G-LIX GRASPER. PT VOMITED IN THE RECOVERY ROOM LIKELY RE-PRECIPITATED BLEEDING AFTER HEMOSTASIS WAS ACHIEVED. INTRA-OPERATIVELY. THE DEVICE PERFORMED AS INTENDED. DOCTOR BELIEVED SUPERFICIAL ARTERY IN INNER STOMACH WALL WAS NICKED WHILE GRASPING THE TISSUE. BLEEDING IS CLEARLY IDENTIFIED AS A POTENTIAL COMPLICATION IN THE DEVICE INSTRUCTIONS FOR USE. DEVICE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    PT UNDERWENT TRANS-ORAL ENDOSCOPIC PROCEDURE TO PLACE TISSUE PLICATIONS WITHIN THE STOMACH. BLEEDING WAS NOTED AT THE SITE OF ONE OF THE PLICATIONS DURING THE PROCEDURE. HEMOSTASIS WAS OBTAINED WITH USE OF ENDOSCOPIC INJECTION OF EPINEPHRINE DURING THE PROCEDURE. PROCEDURE WAS SUCCESSFULLY COMPLETED. POST-PROCEDURE PT VOMITED BLOOD IN RECOVERY ROOM. HEMOGLOBIN DROPPED FROM 12GMS PRE-PROCEDURE TO 8GMS HEMOGLOBIN AFTER THE PROCEDURE. PT WAS TRANSFUSED WITH 2 UNITS OF PRBCS POST-PROCEDURE AND KEPT OVER AN ADDITIONAL DAY FOR OBSERVATION. HEMOGLOBIN REMAINED STABLE, AND REPEAT ENDOSCOPY REVEALED NO ACTIVE BLEEDING. PT WAS DISCHARGED WITHOUT FURTHER INCIDENT OR NEED FOR ANY OTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G-LIX TISSUE GRASPER ENDOSCOPIC TISSUE GRASPER HET USGI MEDICAL C110107

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention