BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 3001358 · Received March 6, 2013

    Report

    Report Number
    1219930-2013-00174
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 12, 2013
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    GAG
    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 TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: ORVIL 25 WAS INSERTED AND ONE OF THE RETAINING SUTURES WAS CUT AND THE TUBE WAS REMOVED. AFTER INSERTING (B)(4) INTO THE ABDOMINAL CAVITY, THE SURGEON ATTEMPTED TO CONNECT THE ANVIL TO THE STAPLER, BUT WOULD NOT CONNECT. HE TRIED SEVERAL TIMES, BUT THE RESULT WAS SAME. A NEW STAPLER WAS OPENED, BUT THE ANVIL COULD NOT BE CONNECTED TO IT. THEREFORE, THE SURGEON EXTENDED THE SMALL INCISION BY 4 OR 5 CM AND PERFORMED ANASTOMOSIS UNDER DIRECT VISION USING PCEEA25. PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEM. OOZING AND TISSUE DAMAGE WERE OBSERVED. THE TISSUE HAD TO BE EXCISED ADDITIONALLY TO REMOVE THE DEVICE. THE CASE WAS EXTENDED BY MORE THAN 30 MINS. NO REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96057 DST SERIES EEA ORVIL 25MM DEVICE DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MFG: 10/01/2012, EXP: 10/31/2017| EEAXL2535, LOT #: P2K0036X, K062850| EEA XL 25MM SINGLE USE STAPLER WITH 3.5MM STAPLES