BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP

    MDR report key: 380838 · Received March 7, 2002

    Report

    Report Number
    2647580-2002-00037
    Event Type
    Injury
    Date Received
    March 7, 2002
    Date of Event
    January 10, 2002
    Report Date
    February 6, 2002
    Manufacturer
    PONCE - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, AFTER THE INSTRUMENT WAS FIRED, THE KNIFE DID NOT CUT COMPLETELY. THE ANASTOMOSIS HAD TO BE RE-CREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP DISPOSABLE STAPLER GAG PONCE - USS NA P1J139

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other