BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z

    MDR report key: 6662379 · Received June 22, 2017

    Report

    Report Number
    3005473391-2017-00104
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    June 6, 2017
    Report Date
    June 22, 2017
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC.
    Product Code
    ODE
    UDI-DI
    00810275011065
    PMA / PMN Number
    K171307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER VERBALLY STATED THERE IS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS RECEIVED AND EVALUATED BY EGS AND NO TROUBLE WAS FOUND WITH THE DEVICE.

    Additional Manufacturer Narrative · 1

    ERRORS LISTED BELOW WERE FOUND IN THE INITIAL REPORT AND ARE BEING CORRECTED IN THIS FOLLOW-UP REPORT: INCORRECT BRAND NAME WAS PROVIDED (ESOPHYX2 HD) AND HAS BEEN UPDATED TO ESOPHYX Z. MODEL #, CATALOG #, AND UNIQUE IDENTIFIER (UDI) # WERE INCORRECT IDENTIFIED AS C02042-01, R2005, AND(B)(4). THESE THREE FIELDS HAVE BEEN CORRECTED TO C02260-02, R2006, AND (B)(4) RESPECTIVELY. PMA/510(K) WAS INCORRECTLY IDENTIFIED AS K142113. THIS HAS BEEN CORRECTED TO K171307.

    Description of Event or Problem · 1

    PRIOR TO DEVICE INSERTION, THE USER REPORTED ISSUES WITH VIDEO OUTPUT FROM THE ENDOSCOPE. INSERTION OF THE DEVICE WAS INITIALLY ATTEMPTED WITHOUT ENDOSCOPIC VISUALIZATION OF THE ESOPHAGUS AND THE USER REPORTED DIFFICULTY INSERTING THE DEVICE. AN EGS REPRESENTATIVE PRESENT AT THE PROCEDURE, REPORTED THE USER USED AN ABNORMALLY LARGE AMOUNT OF FORCE DURING INSERTION. ON THE THIRD ATTEMPT, THE DEVICE WAS SUCCESSFULLY INSERTED INTO THE PATIENT BUT WAS QUICKLY REMOVED AS NO ENDOSCOPIC VISUALIZATION COULD BE ACHIEVED. AFTER FIXING THE ENDOSCOPE VIDEO ISSUE, THE USER REINSERTED THE ENDOSCOPE INTO THE PATIENT AND NOTED BLOOD PRESENT IN THE ESOPHAGUS. IN AN ATTEMPT TO LOCATE THE SOURCE OF THE BLEEDING, THE USER EXTERNALLY OPENED THE PATIENT'S ABDOMEN AND NECK. A PERFORATION WAS FOUND IN THE PROXIMAL ESOPHAGUS MID-CHEST APPROXIMATELY IN THE SAME LOCATION AS RESISTANCE WAS FELT DURING DEVICE INSERTION. THE PERFORATION WAS SUCCESSFULLY TREATED AND THE PATIENT WAS ADMITTED TO THE ICU (B)(6) 2017. AS OF (B)(6) 2017, THE PATIENT WAS STILL IN THE ICU IN STABLE CONDITION AND CONTINUES TO IMPROVE. THE USER VERBALLY STATED THERE IS NO ALLEGATION OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441983 ESOPHYX Z ODE ODE ENDOGASTRIC SOLUTIONS, INC. C02260-02 402375 00810275011065

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R