BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-LIX TISSUE GRASPER

    MDR report key: 2820108 · Received November 1, 2012

    Report

    Report Number
    3004447686-2012-00002
    Event Type
    Injury
    Date Received
    November 1, 2012
    Date of Event
    September 18, 2012
    Report Date
    November 1, 2012
    Manufacturer
    USGI MEDICAL
    Product Code
    HET
    PMA / PMN Number
    K102916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER (HEALTHCARE PROVIDER) DID NOT NOTICE ANY ISSUE WITH THE G-LIX DEVICE IN USE; IT PERFORMED AS INTENDED. IT IS POSSIBLE THAT THE G-LIX MAY HAVE CAUSED SOME SLIGHT BLEEDING, AND THE SUBSEQUENT CLOT FORMED A NIDUS FOR INFECTION.

    Description of Event or Problem · 1

    PT UNDERWENT A TRANS-ORAL ENDOSCOPIC PROCEDURE TO PLACE TISSUE PLICATIONS WITHIN THE STOMACH (POSE PROCEDURE) ON (B)(6) 2012. THE PT WAS DISCHARGED 1 DAY POST-POSE WITHOUT INCIDENT. APPROXIMATELY 3 WEEKS POST-POSE THE PT REPORTED MALAISE, PRODUCTIVE COUGH, AND A SLIGHT FEVER, BUT NO ABDOMINAL PAIN. SAW GI AT (B)(6), AND GIVEN ANTIBIOTIC FOR FLU AND SENT HOME. THREE DAYS LATER ((B)(6) 2012), RETURNED WITH FEVER (39C AT HOME, AND WAS 36C IN ER). WBC COUNT WAS HIGH AT 16K. CT SCAN REVEALED 2CM ABSCESS EXTRA-GASTRICALLY NEAR DB OF STOMACH. PUT ON IV ANTIBIOTICS THURSDAY-MONDAY. ON MONDAY ((B)(6) 2012) THE PT HAD A GASTROSCOPE PROCEDURE. ONE PLICATION IN DISTAL BODY HAD EDEMA AROUND IT AND AREA WAS ERYTHEMATOUS. NO PERFORATION OR FISTULA. PT HAD NO FEVER AT ALL DURING STAY AND WAS IN NO DISTRESS. PT WAS SENT HOME LATE MONDAY ((B)(6) 2012) ON 10 DAY COURSE OF ORAL ANTIBIOTICS WITH NO FURTHER SEQUELAE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G-LIX TISSUE GRASPER ENDOSCOPIC TISSUE GRASPER HET USGI MEDICAL 301010 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R