BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 6157872 · Received December 9, 2016

    Report

    Report Number
    2647580-2016-01058
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 14, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE STAPLED BUT DIDN'T CUT. THE SURGEON HAD TO REMOVE THE DEVICE WITH A LONG CLAMP. THE ANASTOMOSIS WAS TORN OFF, AN ILEOSTOMY HAD TO BE DONE. A SUTURE WITH WIRE HAD TO ME MADE TO CLOSE THE TEAR OF THE ANASTOMOSIS. THE SURGERY TIME WAS EXTENDED BY MORE THAN 30MIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812097 EEA 28MM SINGLE-USE STAPLER STAPLE, IMPLANTABLE GAG COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA28 P5M0220KX

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention