BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER- 33 MM

    MDR report key: 1081508 · Received July 23, 2008

    Report

    Report Number
    3005075853-2008-00648
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    OCW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/23/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE ANASTOMOSIS WAS COMPLETED WITH THE DEVICE. UPON THE LEAK TEST, TWO LEAKS WERE FOUND (ONE AT FIVE O'CLOCK AND ONE AT NINE O'CLOCK). THE PROXIMAL DONUT WAS INCOMPLETE. THE STAPLES WERE THERE, BUT IT IS A POSSIBILITY THEY WERE MALFORMED OR MAYBE THERE WAS SEROSAL TEAR. THE LEAKS WERE OVER SEWN AND A TEMPORARY LOOP COLOSTOMY WAS PERFORMED TO COMPLETE THE PROCEDURE. THE CASE WAS EXTENDED FOUR AND A HALF HOURS. THE PT WAS KEPT IN ICU OVERNIGHT DUE TO THE LONGER THAN NORMAL CASE. THERE WERE NO REMOVAL ISSUES AND ALL STEPS WERE FOLLOWED FOR FIRING THE DEVICE PROPERLY. THE SURGEON WANTS TO GIVE THE ANASTOMOSIS SUFFICIENT TIME TO HEAL AND SAID HE PLANNED TO DO A COLOSTOMY TAKEDOWN AND RECONNECT THE BOWEL THREE MONTHS POST OP. THERE WERE NO ADD'L PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER- 33 MM OCW ETHICON ENDO-SURGERY, LLC NA D4JD20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention