BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL SHORT STAPLER

    MDR report key: 3854911 · Received May 28, 2014

    Report

    Report Number
    2647580-2014-00391
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 7, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOBECTOMY (VATS). ACCORDING TO THE REPORTER: DURING A LOBECTOMY VIA VIDEO THORACOSCOPY, THE STAPLER BUMPED INTO THE TROCAR WHICH MIGHT HAVE SLIGHTLY MOVED THE SULU INSIDE THE DEVICE. THE SURGEON HAD TO FORCE A LITTLE BIT ON THE STAPLER AS THE SULU WOULD NOT EASILY SLIDE IN, BUT SUDDENLY THE BLADE WENT TOO ROUGHLY, CREATING A WOUND ON THE PULMONARY ARTERY. THE SURGEON HAD TO PERFORM A THORACOTOMY FOR HEMOSTASIS. IT IS UNKNOWN WHETHER REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315165 EGIA ULTRA UNIVERSAL SHORT STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC PUERTO RICO P3K0296X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention