BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOMAPHYX 1.1

    MDR report key: 2853180 · Received July 10, 2008

    Report

    Report Number
    3005473391-2008-00004
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC.
    Product Code
    OCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: BASED ON THE CONVERSATION WITH THE DOCTOR, IT IS CONFIRMED THAT DEVICE DID NOT MALFUNCTION AND THE ADVERSE EFFECT WAS CAUSED BY OPERATOR ERROR OF PLACING A FASTENER TOO HIGH IN THE ESOPHAGUS. THROUGH SEEPAGE FROM THE HOLE MADE BY THE FASTENER, THE FASTENER PLACEMENT CAUSED AN INFECTION AND REQUIRED THE SUBSEQUENT PREVENTION THERAPY OF ANTIBIOTICS TO ELIMINATE THE INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ESOPHAGEAL PERFORATION USING A STOMAPHYX DEVICE OCCURRED AND THAT THE PATIENT HAD BEEN REFERRED TO A DOCTOR AT (B)(6) UNIVERSITY, WHO SPECIALIZED IN PERFORATION TREATMENT. THE DOCTOR WHO PERFORMED THE PROCEDURE STATED THAT THE PERFORATION WAS IN THE ESOPHAGUS, CAUSED BY THE PLACEMENT OF A FASTENER. HE STATED HE WASN'T SURE OF HIS LOCATION IN THE GI TRACT AND FIRED A FASTENER IN THE ESOPHAGUS, WHICH IS CONTRAINDICATED, RATHER THAN LOWER, IN THE STOMACH POUCH. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THE PATIENT WAS SENT TO (B)(6) WITH MEDIASTINITIS. A THORACOTOMY WAS PERFORMED TO REMOVE THE FASTENER. THE PATIENT WAS PLACED UNDER OBSERVATION FOLLOWING THAT PROCEDURE AND WAS SUBSEQUENTLY RELEASED FROM THE HOSPITAL. IT WAS REPORTED THAT SHE HAS RECOVERED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOMAPHYX 1.1 OCW ENDOGASTRIC SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R