BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-PROX

    MDR report key: 2251397 · Received September 13, 2011

    Report

    Report Number
    3004447686-2011-00003
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 1, 2011
    Report Date
    September 13, 2011
    Manufacturer
    USGI MEDICAL
    Product Code
    GAT
    PMA / PMN Number
    K061276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR AT FIRST SUSPECTED DEVICE MAY HAVE BEEN RESPONSIBLE FOR CAUSING A PERFORATION OF PLEURAL TISSUE. AFTER REVIEW OF RADIOLOGIC FILMS, PT HISTORY, AND OTHER CONTRIBUTING FACTORS, DOCTOR FEELS PRODUCT DID NOT CONTRIBUTE TO EVENT OR IS SUSPECT IN A PERFORATION.

    Description of Event or Problem · 1

    PT UNDERWENT SUCCESSFUL TRANS-ORAL ENDOSCOPIC PROCEDURE TO PLACE TISSUE PLICATIONS WITHIN THE STOMACH. PT WAS DISCHARGED THE NEXT DAY ON ANTIBIOTICS BECAUSE OF LOW GRADE-FEVER AND SOME LEFT SIDED CHEST AND SHOULDER PAIN. PT WAS INSTRUCTED TO RETURN TO THE HOSP POST-PROCEDURE ON DAY 10 ((B)(6) 2011). MFR NOTIFIED (B)(6) 2011. PT WAS REPORTING INCREASED CHEST PAIN AND NOW SHORTNESS OF BREATH. PT WAS DIAGNOSED WITH A SMALL LEFT SIDED PNEUMOTHORAX WITH EFFUSION. OXYGEN SATURATION WAS 92% ON RE-ADMISSION. CHEST TUBE WAS PLACED. PT TREATED X 10 DAYS AND DISCHARGED WITH NO PERMANENT SEQUELAE. PER TREATING PHYSICIAN, CT SCAN WAS REVIEWED WITH RADIOLOGY AND THERE WAS NO EVIDENCE OF PERFORATION. PT HAD A LUNG BULLA ON THE LEFT SIDE AND RADIOLOGY AND GASTROENTEROLOGIST FELT PNEUMOTHORAX WAS A RESULT OF POOR ANESTHESIA MANAGEMENT DURING GENERAL ANESTHESIA, AS THIS SAME THINGS HAS OCCURRED RECENTLY WITH 3 OTHER PTS WHO DID NOT HAVE A PROCEDURE WITH THE INCISIONLESS OPERATING PLATFORM BY (B)(6) CLINICIAN FEELS IN NO WAY THAT PRODUCT CONTRIBUTED TO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G-PROX FLEXIBLE ENDOSCOPIC GRASPING FORCEPS GAT USGI MEDICAL C110131

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R