BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-LIX TISSUE GRASPER

    MDR report key: 2350360 · Received November 22, 2011

    Report

    Report Number
    3004447686-2011-00005
    Event Type
    Injury
    Date Received
    November 22, 2011
    Date of Event
    September 16, 2011
    Report Date
    October 23, 2011
    Manufacturer
    USGI MEDICAL
    Product Code
    HET
    PMA / PMN Number
    K061268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER (HEALTHCARE PROVIDER) DID NOT NOTICE ANY ISSUE WITH G-LIX DEVICE AND PERFORMED AS INTENDED. FELT EVENT MAY HAVE BEEN RELATED TO A LACK OF ANTIBIOTICS PROPHYLACTICALLY. ALSO, THERE APPEARED TO BE A DELAY IN DIAGNOSIS BY FOLLOW-UP HEALTH CARE PROVIDER.

    Description of Event or Problem · 1

    PT UNDERWENT TRANS-ORAL ENDOSCOPIC PROCEDURE TO PLACE TISSUE PLICATIONS WITHIN THE STOMACH. POSE WAS PERFORMED ON (B)(6) 2011. POST-PROCEDURE DAY 1-8: DAILY PHONE CALLS MADE TO PT WITH NO COMPLAINTS BETWEEN (B)(6) ON POST PROCEDURE DAY 9, PT COMPLAINED OF SOME LEFT RIB PAIN. DAY 15: ON POST-PROCEDURE DAY 15, CALLED IN COMPLAINING OF SHAKES AND CHILLS. SPOKE WITH A GENERAL PRACTIONER BY PHONE ON DAY 15 ((B)(6) 2011). DAY 19 POST-PROCEDURE: (B)(6) 2011 (POST-PROCEDURE DAY 19) STILL FEELING ILL AND TOLD TO SEE LOCAL DOCTOR. POST-PROCEDURE DAY 26 (B)(6) 2011. AWAITING BLOOD WORK THAT DOCTOR DREW ON HER. STILL FEBRILE. HOSPITALIZATION DAY 29 (B)(6) 2011 STILL SICK. SENT TO HOSPITAL. CT SCAN REVEALED INTRA-ABDOMINAL ABSCESSES NEAR LIVER. DRAINS WERE PLACED PERCUTANEOUSLY AND IV ANTIBIOTICS WERE BEGUN. PT WAS DISCHARGED ON (B)(6) 2011. ON (B)(6) 2011 SCHEDULED FOR REPEAT CT SCAN. DRAINS STILL IN. HOPING TO REMOVE THEM BASED ON CT RESULTS. DOCTOR BELIEVED G-LIX MAY HAVE CAUSED SOME SLIGHT BLEEDING EXTRA-GASTRICALLY AND SUBSEQUENT CLOT FORMED A NIDUS FOR INFECTION. NOTE: PRIMARY OPERATOR (SURGEON) SHARED THAT HE DECIDED TO STOP GIVING PROPHYLACTIC ANTIBIOTICS INTRA-OPERATIVELY AS RECOMMENDED BY OTHER DEVICE USERS AFTER HIS FIRST 6 CASES. (B)(6) RECEIVED NO PROPHYLACTIC ANTIBIOTICS. HE HAS SINCE RE-STARTED THAT PRACTICE ON SUBSEQUENT PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G-LIX TISSUE GRASPER ENDOSCOPIC TISSUE GRASPER HET USGI MEDICAL C110107

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R