BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-LIX TISSUE GRASPER

    MDR report key: 1643263 · Received March 25, 2010

    Report

    Report Number
    3004447686-2010-00001
    Event Type
    Injury
    Date Received
    March 25, 2010
    Date of Event
    February 24, 2010
    Report Date
    March 24, 2010
    Manufacturer
    USGI MEDICAL
    Product Code
    KOG
    PMA / PMN Number
    K061268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON STATED THAT DEVICE PERFORMED APPROPRIATELY DURING SURGICAL PROCEDURE AND THAT THE PROCEDURE HAD BEEN SUCCESSFUL AND UNEVENTFUL. SURGEON HAD OBSERVED SOME BLEEDING DURING SURGICAL PROCEDURE (NOT ATYPICAL) AND FELT THAT HE HAD ACHIEVED ADEQUATE HEMOSTASIS AT END OF PROCEDURE. SURGEON SUSPECTS THAT GRASPER MAY HAVE CAUSED INCIDENTAL TRAUMA TO SUBMUCOSAL BLOOD VESSEL. SURGEON STATES THAT PATIENT'S PRIOR SURGICAL HISTORY OF BLEEDING MAY HAVE BEEN A CONTRIBUTING FACTOR TO THIS EVENT.

    Description of Event or Problem · 1

    PATIENT VOMITED BLOOD IN RECOVERY ROOM FOLLOWING SUCCESSFUL ENDOLUMINAL GASTRIC TISSUE PLICATION PROCEDURE. PATIENT RECEIVED 2 UNITS OF BLOOD AND UNDERWENT ENDOSCOPIC EVALUATION. SURGEON CONFIRMED PRESENCE OF ACTIVE BLEEDING SITE WITHIN THE STOMACH WHICH WAS RESOLVED WITH AN ENDOSCOPIC INJECTION OF EPINEPHRINE TO THE BLEEDING SITE. PATIENT WAS DISCHARGED UNEVENTFULLY THE NEXT DAY WITH NORMAL BLOOD WORK RESULTS AND NO REPORTED SYMPTOMS. ABSENCE OF ANY FURTHER SEQUELAE WAS CONFIRMED AT 1 WEEK POST-OP CLINIC FOLLOW UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G-LIX TISSUE GRASPER ENDOSCOPIC TISSUE GRASPER KOG USGI MEDICAL C100044

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention