BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-LIX

    MDR report key: 2997090 · Received March 6, 2013

    Report

    Report Number
    3004447686-2013-00002
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    December 6, 2012
    Report Date
    March 6, 2013
    Manufacturer
    USGI MEDICAL
    Product Code
    HET
    PMA / PMN Number
    K102916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS BELIEVED THAT THE G-LIX SOMEHOW NICKED THE SPLEEN, AND THIS WOULD ONLY HAPPEN IF THE PHYSICIAN DID NOT PAY CAREFUL ATTENTION TO THE LOCATION OF THE G-LIX IN REGARDS TO THE SPLEEN.

    Description of Event or Problem · 1

    CASE COMPLETED WITHOUT COMPLICATIONS. NO ADVERSE SYMPTOMS APPRECIATED. WITHIN 48 HOURS OF DISCHARGE PATIENT WAS READMITTED FOR DEHYDRATION AND THEN DISCHARGED AFTER BEING ADMINISTERED FLUIDS. WITHIN A WEEK THE PATIENT WAS READMITTED FOR SEPSIS, AND A SPLENIC HEMATOMA/ABCESS WAS FOUND USING A CT SCAN. IT IS BELIEVED THE SEPSIS WAS THE REASON FOR THE DEHYDRATION, BUT IT WAS NOT PICKED UP IN THE FIRST READMISSION. ANTIBIOTICS WERE ADMINISTERED, AND THE PATIENT WAS DISCHARGED (AFTER THE SEPSIS WAS GONE AND THE HEMATOMA/ABCESS HAD SHRUNK CONSIDERABLY) WITHOUT ANY FURTHER ISSUES. AT 1 MONTH, THE PATIENT WAS FOUND TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95624 G-LIX ENDOSCOPIC TISSUE GRASPER HET USGI MEDICAL 301010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R TRANSPORT (118180)| G-PROX EZ (208220) USED IN CONJUCTION WITH G-LIX