BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTUCULATOR 60-4.8 SULU

    MDR report key: 3854886 · Received May 22, 2014

    Report

    Report Number
    1219930-2014-00395
    Event Type
    Injury
    Date Received
    May 22, 2014
    Report Date
    May 5, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SEGMENTECTOMY. ACCORDING TO THE REPORTER: MALE PT WHO PRESENTED A LESION IN LUNG WITH NODULE OF POSSIBLE MALIGNITY. SURGEON INFORMS THAT DURING THE THORACOSCOPY IN ORDER TO BIOPSY THE AFFECTED LUNG SEGMENT, THEY OBSERVED THAT THE NODULE WAS NOT VERY DEEP OR CENTRAL, INDEED IT HAD A PERIPHERAL LOCATION AND THERE WAS NOT TOO MUCH TISSUE. BUT WHEN GOING TO PERFORM THE FIRST SHOT IN ORDER TO CUT THE PARENCHYMA AND REMOVE THE NODULE, A SOUND WAS HEARD AS IF THE DEVICE HAD BROKEN. THIS CAUSED THE FIRING NOT TO BE COMPLETED, EITHER THE STAPLING, OR THE STAPLING LINE. THERE WAS POOR STAPLE FORMATION. SO THEY PERFORMED A SECOND AND THIRD FIRING AND THE SAME HAPPENED. SO THEY DECIDED TO PERFORM A THORACOTOMY TO FINISH CUTTING THE MODULE USING A GIA80 3, 5. THE ANALYSIS SHOWED TO BE A ADENOCARCINOMA SO THEY PERFORMED THE LOBECTOMY. DUE TO THE ISSUES EXPERIENCED THERE WAS MORE THAN 30MIN DELAY. THE INCISION WAS EXTENDED MORE THAN 2.5 CM. THERE WAS LESS THAN 500 CC BLEEDING. THE ENDOSCOPY SURGERY WAS RECONVERTED IN AN OPEN ONE. PT WAS DISCHARGED SOME DAYS AFTER THE SURGERY. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306949 ENDO GIA ROTUCULATOR 60-4.8 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention K083519| EGIAUSTND, EGIA ULTRA UNIVERSAL STAPLER,