BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATELINEAR CUTTER

    MDR report key: 3782131 · Received April 30, 2014

    Report

    Report Number
    3005075853-2014-02950
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 7, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SMALL BOWEL RESECTION PROCEDURE, THE PATIENT DEVELOPED A LEAK ON POST OP DAY FIVE. AFTER THE SURGEON FIRED THE BLUE 100MM STAPLER ACROSS THE SMALL BOWEL. CONNECTED THE TWO SMALL BOWEL ENDS JEJUNOCECOSTOMY WITH ANOTHER FIRING OF A BLUE 100MM RELOAD. AND TOPPED OFF CLOSING THE OTOMY WITH A THIRD FIRING OF THE TLC10 100MM STAPLER. THE PATIENT WAS REOPERATED ON (B)(6) (ORIGINAL BOWEL CASE ON 4/1) (PATIENT WAS ADMITTED TO THE HOSPITAL ORIGINALLY FOR A SMALL BOWEL INJURY OBTAINED IN SURGERY WITH A SEPARATE SURGEON/PROCEDURE A FEW DAYS EARLIER). UPON SURGERY THE STAPLE LINE IS REPORTED AS LEAKING. RE-ADMITTED AND PATIENT IS RECOVERING WITH AN ILEOSTOMY. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260258 PROXIMATELINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1