BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 3988254 · Received April 25, 2014

    Report

    Report Number
    1219930-2014-00333
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 3, 2014
    Manufacturer
    COVIDIEN, FORMELRY US
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOBECTOMY. ACCORDING TO THE REPORTER: THE DEVICE WAS PROPERLY LOADED WITH TRISTAPLE RELOAD. THE DEVICE JAMMED PRIOR TO CUT AND SUTURE THE MAIN BRONCHUS. THE DEVICE PARTIALLY FIRED. THE SURGEON USED A NEW DEVICE (ECHELON POWER) OF THE COMPETITOR J+J. NO PT HARM. THERE WAS NO TISSUE DAMAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252337 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMELRY US N3G0047UX

    Patients

    Seq Age Sex Outcome Treatment
    1 K121510| ENDO GIA ADAPTER STANDARD, EGIAADAPT,