BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1882551 · Received October 21, 2010

    Report

    Report Number
    2647580-2010-00849
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 24, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: LAP SIGMOID. ACCORDING TO THE REPORTER: AFTER THE FIRST CLOSURE OF THE ANVIL TO THE STAPLER, THE SURGEON DID NOT LIKE THE WAY THE TISSUE LOOKED AND THOUGHT HE SAW PART OF THE PURSESTRING EXTRUDING OUTSIDE OF THE STAPLER. THE SURGEON OPENED THE STAPLER, REPOSITIONED THE TISSUE, AND THEN CLOSED THE STAPLER AGAIN. THE SURGEON STILL DID NOT LIKE THE WAY THE TISSUE APPEARED, SO HE OPENED THE STAPLER AGAIN, AND SEPARATED THE ANVIL. THE SURGEON THEN DISCOVERED THAT THE ANVIL HAD TILTED PREMATURELY. THE ANVIL AND STAPLER WERE BOTH REPLACED AND FIRED SUCCESSFULLY, WHICH PRODUCED COMPLETE DONUTS AND A FAVORABLE LEAK TEST. OPERATIVE TIME WAS EXTENDED APPROXIMATELY FORTY FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE STAPLER GDW USSC PUERTO RICO P0D0093H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other