BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-LIX

    MDR report key: 3239870 · Received July 17, 2013

    Report

    Report Number
    3004447686-2013-00004
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 7, 2013
    Report Date
    July 16, 2013
    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

    THE PATIENT CLAIMED TO BE ON NO MEDICATION, BUT THE PHYSICIAN FELT THE MUCOSAL LOOKED FRIABLE AND THE PHYSICIAN FELT THE PATIENT MIGHT HAVE BEEN ON A BLOOD THINNER.

    Description of Event or Problem · 1

    TWO EPISODES OF SOME BLEEDING INTRA-OP (ONE IN FUNDUS/ONE IN DB) RELATED TO G-LIX USE THAT REQUIRED PLACEMENT OF CLIPS. POST-PROCEDURE THE PATIENT VOMITED BLOOD. ON RE-ENDOSCOPY, LOTS OF BLOOD IN GASTRUM. MANY CLIPS PLACED. PATIENT REMAINED IN HOSPITAL FOR ONE ADDITIONAL DAY, AND NO FURTHER ISSUES FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331612 G-LIX ENDOSCOPIC TISSUE GRASPER HET USGI MEDICAL 301010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TRANSPORT: (B)(4)