BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX45

    MDR report key: 1852975 · Received October 5, 2010

    Report

    Report Number
    3005075853-2010-05682
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE (B)(4) DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. IT WAS NOTED THAT THE TRIGGER OPENED 3/4 OF THE WAY IN BETWEEN FIRING STROKES. THE FIRING TRIGGER HAD TO BE MANUALLY PUSHED OPEN BETWEEN EACH STROKE. THIS FINDING IS NOT RELATED TO THE REPORTED INCIDENT. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HAND ASSISTED NEPHROURETERECTOMY PROCEDURE, THE SURGEON USED WECK CLIPS AND CLIPPED THE RENAL ARTERY AND SOME BRANCHES OFF THE RENAL VEIN. THE SURGEON PUT THE DEVICE IN THE PATIENT AND CLOSED THE DEVICE ON THE CLIPS. SURGEON WAS INFORMED THAT THE DEVICE SHOULD NOT BE FIRED ON THE CLIPS. THE SURGEON OPENED THE DEVICE AND RE-POSITIONED THE DEVICE. THE DEVICE WAS FIRED AND WHEN THE SURGEON OPENED THE DEVICE, THE VENA CAVA STARTED PUMPING BLOOD. THE SURGEON USED HIS HAND AND PUT PRESSURE ON THE VENA CAVA TO STOP THE BLEEDING. A 35 DEVICE WAS PULLED, BUT THE SURGEON COULD NOT GET ENOUGH TISSUE IN THE JAWS OF THE DEVICE TO SEAL THE OPENING. THEN SURGEON WAS TOLD BY THE ANESTHESIOLOGIST THAT HE WAS PUSHING SO HARD ON THE VENA CAVA THAT THEY WERE NOT GETTING ARTERIAL FLOW BACK TO THE HEART. AT THAT POINT, THE CASE WAS CONVERTED TO OPEN. THE SURGEON PUT A HEMOSTAT ON THE OPENING AND SUTURED THE OPENING CLOSED. THE SURGEON PROCEEDED WITH THE CASE WITH NO FURTHER PATIENT CONSEQUENCE. THE PATIENT LOST 300CC OF BLOOD. THERE WAS NO BLOOD PRODUCT GIVEN TO THE PATIENT. THE PATIENT IS CURRENTLY STABLE.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT DEVELOPED ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY FOR THE PERITONITIS. THE DIANEAL PD4 THERAPY WAS TEMPORARILY WITHDRAWN AND THE EXTRANEAL WAS PERMANENTLY WITHDRAWN ON (B)(6) 2010. THE PATIENT WAS TREATED WITH ANTIBIOTIC THERAPY WITH VANCOMYCIN 1 GM DAILY INTRAPERITONEALY FROM (B)(6) 2010 UNTIL (B)(6) 2010 AND CIPROFLOXACIN 500 MG DAILY INTRAPERITONEALY FROM (B)(6) 2010 UNTIL (B)(6) 2010. THE PATIENT RECOVERED ON (B)(6) 2010 AND WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. ON AN UNREPORTED DATE, PERITONEAL DIALYSIS WITH DIANEAL PD4 1.36% WAS RESTARTED AND THE PERITONITIS DID NOT RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CARTRIDGE