BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-PROX ENDOSCOPIC GRASPER

    MDR report key: 1924649 · Received December 7, 2010

    Report

    Report Number
    3004447686-2010-00003
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 9, 2010
    Report Date
    December 6, 2010
    Manufacturer
    USGI MEDICAL
    Product Code
    HET
    PMA / PMN Number
    K093018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE MANIPULATING THE G-PROX DEVICE IN ORDER TO ENDOLUMINALLY GRASP, A FOLD OF GASTRIC TISSUE, SURGEON REPORTED THAT ONE JAW OF THE G-PROX GRASPER HAD INADVERTENTLY CREATED A SMALL (APPROXIMATELY 5 MM) PERFORATION IN THE GASTRIC WALL. SURGEON PLACED ABDOMINAL TROCARS TO ACCESS THE SITE LAPAROSCOPICALLY AND USED SUTURES TO CLOSE THE PERFORATION. THE PATIENT WAS DISCHARGED THE NEXT DAY IN GOOD CONDITION AND RECOVERED UNEVENTFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G-PROX ENDOSCOPIC GRASPER ENDOSCOPIC GRASPER HET USGI MEDICAL 205333 C100165

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization