BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 21 INST W/O TILT-TOP

    MDR report key: 1083291 · Received July 28, 2008

    Report

    Report Number
    2647580-2008-00433
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 10, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: AFTER APPLYING THE DEVICE THE DOCTOR WAS UNABLE TO REMOVE IT FROM THE ANASTOMOSIS. THE DEVICE WAS THEN OPENED UP COMPLETELY TO DETACH THE ANVIL, AND THEN REMOVED FROM THE PATIENT. SUBSEQUENTLY, AN ENTEROTOMY WAS MADE TO REMOVE THE ANVIL. NO DONUT TISSUE WAS NOTED. THE DOCTOR THEN CLOSED THE ENTEROTOMY, OVER-SEW THE ANASTOMOSIS AS A PRECAUTION, AND THEN DID A DIVERTING ILEOSTOMY TO THE PATIENT. NO BLEEDING OR LEAKS WERE REPORTED. SURGERY TIME WAS EXTENDED ONE HOUR AS A RESULT. NO FURTHER PATIENT INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 21 INST W/O TILT-TOP DISPOSABLE SURGICAL STAPLER GDW PONCE - USS P5A104

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R