BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1002019 · Received February 22, 2008

    Report

    Report Number
    1219930-2008-00167
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 28, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: RESECTION. PATIENT GENDER: UNK. ACCORDING TO THE REPORTER: THE KNIFE CUT ONLY 5/8 OF THE CIRCULAR ANASTOMOSIS. WHEN REMOVING THE INSTRUMENT FROM THE TISSUE, THE SURGEON HAD TO PULL IT OFF, WHICH DAMAGED THE TISSUE. A LOWER RESECTION WAS NEEDED TO PERFORM A NEW ANASTOMOSIS WITH ANOTHER INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN - USS U7A56R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention