BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-LIX TISSUE GRASPER

    MDR report key: 2181344 · Received July 21, 2011

    Report

    Report Number
    3004447686-2011-00001
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 20, 2011
    Manufacturer
    USGI MEDICAL
    Product Code
    HET
    PMA / PMN Number
    K061268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON STATED THAT HE DID NOT EXPERIENCE ANY MALFUNCTIONS WITH THE G-LIX GRASPER. THE DEVICE PERFORMED AS INTENDED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. SURGEON NOTED PRESENCE OF CLOT DURING PROCEDURE BUT DID NOT IDENTIFY ANY ACTIVE BLEEDING AT THE CONCLUSION OF THE PROCEDURE. SURGEON SUSPECTS THAT GRASPER MAY HAVE CAUSED INCIDENTAL TRAUMA TO SUBMUCOSAL BLOOD VESSEL WHILE GRASPING TISSUE. LOW BLOOD PRESSURE, TYPICAL WHILE UNDER GENERAL ANESTHESIA DURING A SURGICAL PROCEDURE, MAY HAVE MASKED THE BLEEDING. PT'S VOMITING IN THE RECOVERY ROOM MAY HAVE THEN ACCELERATED THE BLEEDING. BLEEDING IS A POTENTIAL COMPLICATION IDENTIFIED IN THE DEVICE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    PT VOMITED BLOOD IN RECOVERY ROOM FOLLOWING SUCCESSFUL ENDOLUMINAL GASTRIC TISSUE PLICATION PROCEDURE. PT RETURNED TO OPERATING ROOM AND SURGEON USED ENDOSCOPE TO PERFORM THOROUGH INSPECTION OF THE STOMACH. PRESENCE OF CLOT IN THE FUNDUS WAS NOTED; HOWEVER, NO ACTIVE BLEEDING WAS FOUND. SURGEON INJECTED EPINEPHRINE AROUND CLOT, PT RECEIVED TRANSFUSION, AND WAS OBSERVED OVERNIGHT IN HOSPITAL. PT DISCHARGED NEXT MORNING SYMPTOM-FREE. PT CONTACTED BY PHONE 48 HRS POST-DISCHARGE AND CONFIRMED NO SUBSEQUENT SYMPTOMS OR SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G-LIX TISSUE GRASPER ENDOSCOPIC TISSUE GRASPER HET USGI MEDICAL C100321

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention