BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP

    MDR report key: 1081300 · Received July 22, 2008

    Report

    Report Number
    2647580-2008-00425
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 21, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE SURGEON HAD NOTED THAT THE TISSUE ON THE ANVIL WAS SLIGHTLY THINNER THAN USUAL BUT DECIDED TO STILL USE THE STAPLER. AFTERWARDS THE SURGEON ADMINISTERED AN AIR TEST WHICH SHOWED 2 TO 3 BUBBLES FROM THE ANASTOMOSIS. FURTHERMORE, THE DISTAL TISSUE SPECIMEN WAS MISSING MAJORITY OF THE TISSUE. THE SURGEON THEN DECIDED TO OVER-SEW TRANS-ANALLY THE AREA WHICH THEN RESULTED IN THE POSITIVE OUTCOME (COLOSTOMY FOR 4-6 WEEKS). NO PT INJURY WAS REPORTED. THE PT IS IN WELL CURRENT CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R