BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 21MM SINGLE USE STAPLER WITH

    MDR report key: 3170143 · Received June 7, 2013

    Report

    Report Number
    2647580-2013-00328
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS REVISION. ACCORDING TO THE REPORTER: ORVIL WAS PLACED IN STOMACH POUCH. THE 21MM EEA WAS INTRODUCED INTO SMALL BOWEL TO ANASTOMOSE THE GJ AND THE ANVIL FROM THE ORVIL WOULD NOT CONNECT TO THE EEA (WOULD NOT COVER ORANGE BAND ON EEA). OPENED ANOTHER EEA AND WAS ABLE TO CONNECT AND FIRE THE STAPLER. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. NO REINFORCEMENT MATERIAL WAS USED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253827 EEA XL 21MM SINGLE USE STAPLER WITH DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY USSC P2K0615X

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other (B)(4)| DST SERIES EEA ORVIL 21MM DEVICE: EEAORVIL21