BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 3122551 · Received May 17, 2013

    Report

    Report Number
    2647580-2013-00290
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 26, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: DR (B)(6) PERFORMED A LOW ANTERIOR RESECTION ON THE (B)(6) 2013. SHE USED A 28MM 3.5MM EEA. THE DONUTS WERE COMPLETE BUT APPARENTLY VERY THIN. SHE DID AN OVER SEW WITH SILK SUTURE FOR EXTRA SECURITY. SHE PERFORMED A LEAK TEST AND DID NOT SEE ANY BUBBLES. SIX DAYS LATER, THE PT HAD A LEAK AT THE EEA ANASTOMOSIS SITE. THE SURGEON HAD TO RE-OPERATE ON THE PT ON (B)(6) 2013, AND DIVERT TO AN OSTOMY. THERE WAS UNANTICIPATED TISSUE LOSS. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218634 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P2L0316X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other