BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP

    MDR report key: 1041155 · Received May 12, 2008

    Report

    Report Number
    2647580-2008-00272
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 16, 2008
    Manufacturer
    PONCE-USS
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION WITH END-TO-END ANASTOMOSIS. PT GENDER: UNK. ACCORDING TO THE REPORTER: THE DEVICE DID NOT CUT THE TISSUE AFTER FIRING. THE SURGEON MANUALLY CUT AND SUTURED THE OUTLINE OF STAPLE LINE. SURGERY WAS EXTENDED MORE THAN 30 MINS AS A RESULT. NO BLOOD LOSS WAS REPORTED. NO PT DETAILS WERE DISCLOSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention