BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 45-3.5 DLU

    MDR report key: 3054733 · Received April 8, 2013

    Report

    Report Number
    1219930-2013-00218
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOBECTOMY. ACCORDING TO THE REPORTER: AS REPORTED IN THE CASE REPORT ENTITLED "BRONCHOSCOPE REMOVAL OF STAPLE-LINE REINFORCEMENT MATERIAL" RECEIVED FOR PUBLICATION APRIL 28, 2011; ACCEPTED JUNE 8, 2011 FROM THE DEPARTMENT OF SURGICAL II, FACULTY OF MEDICINE, UNIVERSITY OF MIYAZAKI, MIYAZAKI, JAPAN: A (B)(6) MAN UNDERWENT A RIGHT UPPER LOB LOBECTOMY AND LYMPH NODAL DISSECTION FOR A POORLY DIFFERENTIATED ADENOCARCINOMA LUNG CANCER IN (B)(6) 2002. AN ENDOGIA II 45MM-3.5 STAPLE CARTRIDGE COVERED WITH ARTIFICIAL REINFORCEMENT MATERIAL, THAT IS, EPRFE (SEAMGUARD, W.L. GORE + ASSOCIATES, INC., FLAGSTAFF, AZ) WAS FIRED TWICE TO SEPARATE THE INCOMPLETE INTERLOBAR FISSURE BETWEEN THE UPPER AND LOWER LOBES. TO RESECT THE RIGHT UPPER LOBE BRONCHUS, AN ENDOGIA II STAPLE CARTRIDGE WAS USED. IN (B)(6) 2008, THE PATIENT DEVELOPED A SEVERE PRODUCTIVE COUGH. DURING FLEXIBLE BRONCHOSCOPY, A STAPLE-LINE REINFORCEMENT MATERIAL WAS FOUND PROTRUDING INTO THE RIGHT MAIN STEM BRONCHUS LUMEN FROM ITS MEMBRANEOUS WALL. THREE DIMENSIONAL COMPUTED TOMOGRAPHIC SCANNING OF THE CHEST REVEALED THAT THE MAIN BODY OF THE STAPLE-LINE REINFORCEMENT MATERIAL WAS LOCATED IN THE RIGHT MEDIASTINUM WITH ONE OF ITS ENDS MIGRATING INTO THE RMB. UNDER GENERAL ANESTHESIA, THE MIGRATED PORTION OF THE REINFORCEMENT MATERIAL WAS SEVERED USING ENDO-BRONCHIAL SCISSORS THROUGH THE FLEXIBLE BRONCHOSCOPE ALID REMOVED (FIGS. IC-E), LEAVING ITS MEDIASTINAL PORTION UNTOUCHED. THE PATIENT EXPERIENCED A SIGNIFICANT IMPROVEMENT IN HIS SYMPTOMATOLOGY. AFTER 1 YEAR, IN (B)(6) 2009, THE PATIENT DEVELOPED RECURRING PRODUCTIVE COUGH. A REPEAL CHEST 30-CT SCANNING AND A FLEXIBLE BRONCHOSCOPY REVEALED A RESIDUAL STAPLE LINE PROTRUDING INTO THE RMB. ONCE AGAIN, UNDER GENERAL ANESTHESIA, USING A FLEXIBLE BRONCHOSCOPE, WE TRIED TO TRIM THE NECK OF THE STAPLE-LINE REINFORCEMENT MATERIAL; HOWEVER, OUR ATTEMPTS WERE UNSUCCESSFUL DUE TO DIFFICULTY IN MANIPULATION OF THE INSTRUMENTS. EVENTUALLY, WE TIGHTLY GRASPED THE STAPLE LINE WITH A BIOPSY-FORCEPS THROUGH THE FLEXIBLE BRONCHOSCOPE AND PUSHED IT INTO A PERIPHERAL BRONCHUS; ONCE IT WAS TOTALLY EXTRACTED OUT OF THE MEDIASTINUM, IT WAS PULLED OUT FROM THE ENDOBRONCHIAL TREEA FOLLOW-UP CHEST CT SCAN REVEALED NO RESIDUAL MATERIAL EITHER IN THE THORAX OR MEDIASTINUM, AND THE PATIENT HAS REMAINED SYMPTOM FREE EVER SINCE. THE LOT NUMBER OF THE (B)(4) WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144553 ENDO GIA II 45-3.5 DLU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R