BEUDAMED
    FDA Adverse Event Death Summary report: N

    G-PROX

    MDR report key: 2587445 · Received May 21, 2012

    Report

    Report Number
    3004447686-2012-00001
    Event Type
    Death
    Date Received
    May 21, 2012
    Date of Event
    April 17, 2012
    Report Date
    May 21, 2012
    Manufacturer
    USGI MEDICAL
    Product Code
    HET
    PMA / PMN Number
    K103688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICIAN DOES NOT FEEL THAT THIS REPORTED ADVERSE EVENT IS RELATED TO INJURY CAUSED BY USE OF THE G-PROX DEVICE, BUT DUE TO HER UNDERLYING CORONARY VASCULAR DISEASE.

    Description of Event or Problem · 1

    PT UNDERWENT ENDOSCOPIC REVISION OF HER ROUX-EN-Y GASTRIC BYPASS PROCEDURE ON (B)(6) 2012 WITH USGI INCISIONLESS OPERATING PLATFORM (IOP) WITHOUT INCIDENT. PT DISCHARGED SAME DAY. PT RE-ADMITTED ON (B)(6) 2012 AT ANOTHER INSTITUTION COMPLAINING OF MALAISE, PALPITATIONS, AND SHORTNESS OF BREATH. NO ABDOMINAL PAIN, NAUSEA, OR VOMITING. ON EXAM, PT FOUND TO BE IN NEW ONSET ATRIAL FIBRILLATION WITH FEVER OF 101. CXR CONSISTENT WITH CONGESTIVE HEART FAILURE. O2 SAT LOW AT 92%. PT WAS RATE CONTROLLED, GIVEN DIURETICS, OXYGEN, AND ANTIBIOTICS FOR SUSPECTED UTI. PT HAD RETURNED TO SINUS RHYTHM ON ADMISSION TO FLOOR. ON FLOOR, PT HAD REVERTED TO ATRIAL FIBRILLATION AND WAS TRANSFERRED TO CARDIAC UNIT. LATER THAT EVENING, PT WENT INTO VENTRICULAR FIBRILLATION AND CPR WAS BEGUN WHICH WAS UNSUCCESSFUL. PT DECLARED DEAD AT 5 AM ON (B)(6) 2012. NO AUTOPSY PERFORMED. MFR NOTIFIED OF EVENT ON (B)(40 2012. OPERATOR OF IOP AND CLINICIANS WHO CARED FOR HER ON HOSPITALIZATION FELT CAUSE OF DEATH WAS ACUTE VENTRICULAR FIBRILLATION WITH UNDERLYING CORONARY AND PERIPHERAL VASCULAR DISEASE AND NOT DIRECTLY RELATED TO IOP EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G-PROX FLEXIBLE ENDOSCOPIC GRASPING FORCEPS HET USGI MEDICAL 208220 C120090

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| H G-LIX (K061268)| TRANSPORT(K072405) USED IN CONJUNCTION WITH G-PROX| G-CATH (K102916)