BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX2 - LINK DESIGN - SHORT

    MDR report key: 2552295 · Received April 29, 2012

    Report

    Report Number
    3005473391-2012-00060
    Event Type
    Injury
    Date Received
    April 29, 2012
    Date of Event
    March 28, 2012
    Report Date
    April 5, 2012
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATION OF PRODUCT MALFUNCTION AND THE DEVICE WAS DISPOSED OF PER THE HOSPITAL'S STANDARD OPERATING PROCEDURE AND IS NOT AVAILABLE FOR AN EVALUATION.

    Description of Event or Problem · 1

    TWO DAYS FOLLOWING A SUCCESSFUL TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE, THE PATIENT BEGAN TO HAVE EPIGASTRIC PAIN. THE PHYSICIAN PERFORMED AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND CT SCAN WITH CONTRAST AND EVERYTHING APPEARED TO BE NORMAL. THE PATIENT THEN STARTED EXPERIENCING MORE EPIGASTRIC PAIN, BLOATED ABDOMEN, TACHYCARDIA AND ILEUS. IT WAS THEN DECIDED TO TAKE THE PATIENT BACK TO SURGERY AND PERFORM A DIAGNOSTIC LAPAROSCOPY WHICH REVEALED 150ML OF GREEN FLUID IN THE UPPER RIGHT QUADRANT. A CLOSER LOOK AT THE GASTROESOPHAGEAL JUNCTION FOUND NO PERFORATIONS AND THE STOMACH INSUFFLATED, THERE WAS NO LEAKAGE. THE PATIENT DEVELOPED ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) AND WAS INTUBATED AND KEPT ON A VENTILATOR. IT IS BELIEVED THAT A MICROPERFORATION OCCURRED DURING THE TIF PROCEDURE, THAT HAD RESOLVED SPONTANEOUSLY BY THE END OF THE PROCEDURE AND SUBSEQUENTLY THAT WOULD EXPLAIN THE 150ML OF GREEN FLUID FOUND DURING THE DIAGNOSTIC LAPAROSCOPY. THE PATIENT IS REPORTED AS DOING FINE AND HAS SINCE BEEN TAKEN OFF OF THE VENTILATOR AND HAS GONE HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 - LINK DESIGN - SHORT ODE ODE ENDOGASTRIC SOLUTIONS, INC R2002

    Patients

    Seq Age Sex Outcome Treatment
    1 24 Hospitalization| R