BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS STAPLER

    MDR report key: 3963189 · Received July 29, 2014

    Report

    Report Number
    3005075853-2014-05306
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: REP CALLED BACK TO REPORT ESTIMATED BLOOD LOSS UNKNOWN, HOWEVER NO TRANSFUSION WAS REQUIRED. PATIENT IS REPORTED TO BE DOING FINE AS OF (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THAT DURING A COLON RESECTION, THE DEVICE WAS FIRED AND REMOVED. THE SURGEON CHECKED THE DONUTS AND THEY WERE PERFECT. THE PATIENT WAS SENT TO PACU FOR RECOVERY AND THEN TO THE FLOOR. THREE HOURS LATER THE PATIENT WAS BLEEDING. THE SURGEON INSERTED A COLONOSCOPE AND AT THE STAPLE LINE THERE WAS A VESSEL THAT WAS ¿PUMPING BLOOD.¿ THE PATIENT WAS TAKEN BACK TO SURGERY AND THE SURGEON CLIPPED THE BLEEDING VESSEL. THE AMOUNT OF BLOOD LOSS IS UNKNOWN AT THIS TIME. IT IS UNKNOWN IF THE PATIENT RECEIVED A BLOOD TRANSFUSION. THE PATIENT REMAINS IN THE HOSPITAL AND IS DOING WELL. NO DEVICE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441035 PROXIMATE ILS STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1