BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ADAPTER STANDARD

    MDR report key: 3924698 · Received June 25, 2014

    Report

    Report Number
    1219930-2014-00474
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 2, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY US SUR
    Product Code
    GDW
    PMA / PMN Number
    K121510
    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: LOBECTOMY. ACCORDING TO THE REPORTER: A DOCTOR TRIED TO CONFIRM IF THE JAW COULD BE CLOSED AND OPENED NORMALLY AFTER LOADING SULU, CONFIRMED THE TIP OF JAW GOT ARTICULATED AUTOMATICALLY EVEN WHEN THE SULU DID NOT TOUCH THE TOGGLE. HOWEVER, USING THIS ONE THE FIRING WAS DONE AND NO PROBLEM IN THE STAPLE LIKE WAS CONFIRMED. THE CASE WAS COMPLETED WITH NO PROBLEM WITHOUT EXCHANGE OF PRODUCT. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. NOTHING FELL INTO THE CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369600 ENDO GIA ADAPTER STANDARD REUSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, FORMERLY US SUR

    Patients

    Seq Age Sex Outcome Treatment
    1 IDRVULTRA1,| EGIA 45 CURVED TIP ARTICULATING VAS/MED SULU,| IDRIVE ULTRA POWERED HANDLE 1,| K121510| K101444.| EGIA45CTAVM,