BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1002016 · Received February 22, 2008

    Report

    Report Number
    1219930-2008-00168
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    December 28, 2007
    Report Date
    January 28, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOID RESECTION. ACCORDING TO THE REPORTER: THE TRANSECTION DID MAKE A COMPLETE CUT OF THE ANASTOMOSIS AND UPON REMOVING THE DEVICE THE TISSUE WAS TORN. SURGEON RESECTED THAT PORTION OF TISSUE AND RE-ANASTOMOSED WITH A NEW INSTRUMENT. SURGERY WAS EXTENDED BY ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN - USS U7E29

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR