BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 1943882 · Received January 3, 2011

    Report

    Report Number
    3005075853-2011-00010
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. SURGEON EMAILED REP AND STATED HE HAD A LEAK. HE HAD THE PATIENT DRINK BLUE COLORED WATER AND IT IMMEDIATELY CAME THRU THE JP DRAIN. REP TALKED TO HIM AND HE DOES NOT KNOW IF IT IS THE CIRCULAR STAPLER OR THE ECHELON STAPLER. HE BELIEVES THE LEAK IS AT THE POUCH OR AT THE GJ. HE IS NOT TAKING THE PATIENT BACK TO SURGERY, PRESENTLY HE IS GOING TO MONITOR THE PATIENT TO SEE IF IT WILL HEAL ON ITS OWN. THE LEAK WAS DETECTED TODAY AND THE PATIENT HAD SURGERY YESTERDAY, A LAPAROSCOPIC GASTRIC BYPASS A POST- OP (B)(6) LEAK. HE DID DO A LEAK TEST IN SURGERY AND THERE WAS NO LEAK. ONLY VARIABLE IS THE USE OF A DIFFERENT BUTTRESS MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC GASTRIC BYPASS. THE SURGEON PAGED THE REP AND ADVISE HE HAD THE PATIENT DRINK BLUE COLORED WATER AND IT IMMEDIATE CAME THROUGH THE JP DRAIN. POST OP (B)(6) LEAK: MONITORING PATIENT AT THIS TIME. LEAK TEST WAS PERFORMED DURING THE PROCEDURE WITH NO ISSUES. NO SURGICAL INTERVENTION HAS BEEN PERFORMED AT THE TIME OF THIS REPORT. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention