BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60

    MDR report key: 2243709 · Received September 12, 2011

    Report

    Report Number
    3005075853-2011-03754
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE OPERATION WAS PERFORMED BY CUTTING THE ANTRUM OF THE STOMACH DISTALLY. AFTER A COUPLE OF DAYS THEY DISCOVERED THAT THE STAPLE LINE WAS COMPLETELY OPEN WHILE AFTER THE RESECTION IT WAS ENTIRE. THEY THINK THAT THE PROBLEM IS THE THICKNESS, THIS ANATOMICAL PART IS PROBABLY HIGHER THAN 2 MM AFTER THE COMPRESSION (GREEN RELOAD WAS USED). A SECOND OPERATION WAS NEEDED. THE DEVICE WAS DISCARDED. THE SURGEON HAS OPERATED 15 GASTRIC BYPASSES WITH THE REMOVAL OF THE MAIN PART OF THE STOMACH. HE THINKS THAT THIS WILL CAUSE LOWER LONG TERM "CANCEROGENIC" PROBLEMS TO THE STOMACH. THE SURGEON IS NOW PERFORMING A MORE PROXIMAL TRANSACTION OF THE ANTRUM AND HE IS OVER SEWING THE LINE, AT THE MOMENT HE HAS HAD NO FURTHER PROBLEMS. SALES REP STATED ON THE PHONE THAT HE WAS PRESENT AT THE RE- OPERATION. TISSUE WAS THICKER THAN 2MM THEREFORE OF LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RELOAD PRODUCT #-ECR60G