BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP

    MDR report key: 1163125 · Received September 16, 2008

    Report

    Report Number
    2647580-2008-00539
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 29, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION WITH END-TO-END ANASTOMOSIS. ACCORDING TO THE REPORTER: AFTER APPLYING THE DEVICE, IT WAS NOTICED THAT THE TISSUE WAS NOT COMPLETELY CUT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO BLEEDING AND NO TISSUE DAMAGE WERE REPORTED.

    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 P8C0053J

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention