BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD ECH FLEX 60MM 44CM SHAFT

    MDR report key: 3559510 · Received January 7, 2014

    Report

    Report Number
    3005075853-2014-00151
    Event Type
    Injury
    Date Received
    January 7, 2014
    Report Date
    December 12, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A ROUX-EN-Y PROCEDURE, A POST-OP OBSTRUCTION OCCURRED AT THE JEJUNOSTOMY SITE. DURING THE ORIGINAL PROCEDURE, THE DEVICE FUNCTIONED AS INTENDED AND A JAGGED CUT LINE WAS NOTED. TWO DAYS POST-OP, A SWALLOW TEST WAS PERFORMED AND THE PATIENT BEGAN VOMITING WATER AND THE PROTEIN SHAKE ADMINISTERED DUE TO AN OBSTRUCTION AT THE JEJUNOSTOMY SITE. IT WAS NOTED THAT THERE WAS A POSSIBLE STRUCTURE IN THE JEJUNOJEJUNOSTOMY THAT PRESENTED WITH A DECOMPRESSED JEJUNUM DISTAL TO THE ANASTAMOSIS. SURGEON REMOVED SOME OMENTUM TO TRY AND ALLEVIATE ANY KINKING OF THE TISSUE. A SECOND SURGICAL LAPAROSCOPY WAS PERFORMED TWO DAYS LATER AS VOMITING CONTINUED. SURGEON DECIDED TO CREATE A NEW ENTEROENTEROSTOMY BYPASSING THE ORIGINAL J TO J. PATIENT IS NOW DOING WELL. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10991 PWRD ECH FLEX 60MM 44CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RELOAD ECR60W