BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ARTIC LNR CUTR NO KNIFE

    MDR report key: 6988204 · Received October 30, 2017

    Report

    Report Number
    3005075853-2017-05780
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Report Date
    October 3, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS A LOT/BATCH WAS NOT PROVIDED, A DEVICE HISTORY COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: FOR MORE SAFETY: NO-KNIFE STAPLING FOR VASCULAR DIVISION DURING VIDEO-ASSISTED THORACOSCOPIC SURGERY. AUTHORS: JUNICHI YOSHIDA, SOJIRO SATA. CITATION: GEN THORAC CARDIOVASC SURG (2007) 55:80¿81. DOI 10.1007/S11748-006-0076-4. THE AUTHORS HAVE USED NO-KNIFE STAPLERS AND HAVE DIVIDED BETWEEN THE STAPLE LINES WITHOUT EVENT AND SHOW THIS TECHNIQUE TO BE A RISK MANAGEMENT ALTERNATIVE. THEIR VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) APPROACH INCLUDES A LATERAL 8-CM THORACOTOMY ALONG THE THIRD TO SIXTH RIBS WHILE CREATING TWO 1CM PORTS. AFTER EXPOSING THE PULMONARY ARTERY OR THE VEIN FOR AT LEAST 10 MM FOR THE WIDTH OF THE JAW ¿ I.E. THE ANVIL OF THE NK STAPLER (ENDOPATH ETS45-FLEX NO KNIFE NAW), A PENROSE DRAIN IS THREADED BEHIND THE VESSEL. THE ANVIL IS INSERTED INTO THE DRAIN, THREAD IT BEHIND THE VESSELS, AND REMOVE THE DRAIN. THE VESSELS ARE STAPLED AND DIVIDED BETWEEN THE SIX-ROW STAPLE LINES, LEAVING 3 OR 4 ROWS ON THE CARDIAC SIDE. IN ONE CASE DURING THE LEARNING CURVE PERIOD, THE AUTHORS UNINTENTIONALLY INTERRUPTED FIRING, ONLY TO FIND THAT FURTHER STAPLING WAS IMPOSSIBLE. AFTER REMOVAL WAS POSSIBLE, THE AUTHORS FOUND THE VESSEL STAPLED HALFWAY. THE AUTHORS HAND-SEWED THE REST AND DIVIDED THE TISSUE WITHOUT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766439 ENDOPATH ARTIC LNR CUTR NO KNIFE STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1