BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP

    MDR report key: 1001041 · Received February 20, 2008

    Report

    Report Number
    2647580-2008-00088
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 25, 2008
    Manufacturer
    PONCE-USS
    Product Code
    GAG
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION WITH END-TO-END ANASTOMOSIS. ACCORDING TO THE REPORTER: THE DEVICE DID NOT CUT COMPLETELY AND IT WAS DIFFICULT TO REMOVE FROM THE PT. THE ANVIL WAS RELEASED FROM THE DEVICE AND THE SURGEON MANUALLY CUT THE UNCUT AREA. THE ANVIL WAS THEN REMOVED AND THE SURGEON SUTURED THE AREA AND COMPLETED THE PROCEDURE. SURGERY WAS EXTENDED ABOUT ONE HOUR AS A RESULT. NO BLEEDING OCCURRED AND NO PT INJURY WAS REPORTED. THE PT IS CURRENTLY IN WELL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLER GAG PONCE-USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention