BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES* EEA* ORVIL* 25MM DEVICE

    MDR report key: 4221479 · Received November 3, 2014

    Report

    Report Number
    1219930-2014-00998
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K093402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: THE ANVIL WOULD NOT ATTACH WITH THE STAPLER. THE SURGEON USED THE ORIGINAL ANVIL THAT THE STAPLER CAME WITH. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS AN UNANTICIPATED EXTENSION OF INCISION BY 4 INCHES. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. THERE WAS AN EXTENSION OF OPERATING TIME OF OVER 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701955 DST SERIES* EEA* ORVIL* 25MM DEVICE DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EEAORVIL25 N4F0223UX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other