BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEA 28 INSTR. W/TILT TOP

    MDR report key: 1052814 · Received May 27, 2008

    Report

    Report Number
    2647580-2008-00295
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 21, 2008
    Report Date
    May 2, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR COLON RESECTION. ACCORDING TO THE REPORTER: DURING AN OPEN LOW ANTERIOR COLON RESECTION, IT WAS DETERMINED THAT ONLY 2/3 - 3/4 OF THE STAPLES HAD FIRED FROM THE CEEA STAPLER, ALTHOUGH THE ENTIRE CIRCLE WAS CUT. ALSO, THE INNER "DONUT" SPECIMEN WAS STUCK WITH DEPLOYED AND PARTIALLY DEPLOYED STAPLES TO THE CENTER POST ON THE ANVIL. BOWEL ANASTOMOSIS WAS INCOMPLETE. REQUIRED ADD'L SURGERY TIME ( 1 1/2 HRS) TO RE-DO LOW COLON RESECTION. PT DID WELL POSTOPERATIVELY BUT DID DEVELOP AN ILEUS. A PICC LINE WAS INSERTED ON POST-OP DAY 6 FOR TOTAL PARENTERAL NUTRITION. PT DID RECOVER BOWEL FUNCTION AND WAS DISCHARGED TO HOME ON POST-OP DAY 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEA 28 INSTR. W/TILT TOP DISPOSABLE SURGICAL STAPLER GDW PONCE - USS P7L0369J

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention