BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSEAL

    MDR report key: 2063877 · Received April 20, 2011

    Report

    Report Number
    3005075853-2011-01583
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 26, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 DAYS POST-OP A LIVER RESECTION PROCEDURE, THE PATIENT FELL AND WAS FOUND TO BE HYPOTENSIVE. PROTIME ELEVATED 41 (PT/PTT WERE NORMAL PREOP). CT SCAN RESULTS SHOWED BLEEDING FROM SMALL BOWEL MESENTERY. PATIENT WAS NOT TAKEN BACK TO OPERATING ROOM. BLOOD WAS GIVEN ON POD #5. ALSO TREATED AND STOPPED COAGULOPATHY. PATIENT WAS GIVEN BLOOD POST-OP. THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    INFORMATION OBTAINED FROM SURGEON: THE CASE WAS A KLATSKINS TUMOR WHICH PROCEEDED WITH MINIMAL BLOOD LOSS. A FEW DAYS POSTOPERATIVELY, THE PATIENT'S INR UNEXPECTEDLY BEGAN TO RISE AND THE PATIENT SUBSEQUENTLY BLED FROM THE ROUX LIMB MESENTERY. IT WAS ON THE MESENTERY THAT THE ENSEAL DEVICE WAS USED. THIS PATIENT'S CAUSE OF ELEVATED INR WAS A PRIMARY HEPATIC FAILURE AND THE BLEEDING MOST LIKELY CAUSED BY THIS SYNTHETIC ANTICOAGULATION. THE PATIENT SURVIVED AND HAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NSEAL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention GENERATOR