BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 3170164 · Received June 7, 2013

    Report

    Report Number
    1219930-2013-00428
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 20, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP. TOTAL GASTRECTOMY. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, THE ORVIL AND THE STAPLER COULD NOT BE CONNECTED. THEREFORE, THE SURGEON CUT THE ESOPHAGUS STUMP AND REMOVED THE ORVIL, AND THE ESOPHAGUS WAS CLOSED WITH TRI-STAPLE AGAIN AND A NEW ORVIL WAS INSERTED THROUGH THE MOUTH. HOWEVER, THE ORVIL COULD NOT BE CONNECTED. AT THIS POINT, THE SURGICAL TIME WAS EXTENDED BY MORE THAN 3 HOURS, AND THE PROCEDURE WAS CONVERTED INTO OPEN. THE 1ST ORVIL WAS INSERTED FROM THE ESOPHAGUS STUMP AND THE STUMP WAS CLOSED WITH PURSE-STRING SUTURE, AND FINALLY THE ORVIL COULD BE CONNECTED TO THE STAPLER. THERE WAS NO BLEEDING AND NOTHING FELL INTO CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253980 DST SERIES EEA ORVIL 25MM DEVICE DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SUR N3B0061URX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R| S MANUFACTURE DATE: 08/2012| EEA XL 25MM SINGLE USE STAPLER WITH 3.5MM STAPLES:| EEAXL2535, LOT #P2H0738X, EXP. DATE: 08/31/2017