BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE VASCULAR LINEAR STAPLER - 30 MM

    MDR report key: 1964270 · Received January 19, 2011

    Report

    Report Number
    3005075853-2011-00255
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. USER FACILITY MEDWATCH (B)(4). THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    PER USER FACILITY (B)(4), DURING A POSTER LATERAL THORACOTOMY FOR LEFT LOWER LOBECTOMY PROCEDURE THE RIBS WERE SPREAD, PLEURAL SPACE INSPECTED, WE THEN TOOK DOWN THE INFERIOR PULMONARY LIGAMENT AND OPENED THE PARIETAL PLEURA ON EITHER SIDE OF HILUM. INFERIOR PULMONARY VEIN WAS TAKEN WITH A STAPLER. WE THEN ENTERED THE FISSURE AND IDENTIFIED THE PULMONARY ARTERY BRANCHES GOING TO THE SUPERIOR SEGMENT OF LOWER LOBE AND INFERIOR SEGMENTS OF LOWER LOBE. BRANCH GOING TO SUPERIOR SEGMENT WAS TAKEN WITH A STAPLER. WE THEN PLACED A STAPLER ON THE BRANCHES GOING TO THE LOWER LOBE MAKING SURE THAT WE DID NOT TAKE BRANCH GOING TO LINGULA. WE APPLIED THE STAPLER BUT THE STAPLER MISFIRED AND LEFT A HOLE IN THE PULMONARY ARTERY HERE. WE PLACED CLAMPS PROXIMALLY AND DISTALLY, BUT DID LOSE SOME BLOOD AT THIS POINT. WE TRANSECTED THE PULMONARY ARTERY AND OVER SEWED BOTH CUT ENDS W/PROLENE SUTURE. THE CLAMPS REMOVED AND WE HAD ADEQUATE HEMOSTASIS. WE THEN DISSECTED OUT THE TWO MAIN BRONCHIAL BRANCHES GOING TO LOWER LOBE. THESE WERE THEN CLAMPED WITH STAPLER. WE INFLATED THE LEFT LUNG AND MADE SURE THE LEFT UPPER LOBE INFLATED FULLY AND THAT NO AIR WAS GOING TO THE LOWER LOBE. ONCE THIS WAS INSURED, WE DEFLATED THE LEFT UPPER LOBE AND FIRED THE STAPLER. THE BRONCHUS WAS EXCISED WITH STAPLER. THE FISSURE WAS TAKEN WITH STAPLERS AND THE LUNG WAS REMOVED AND PASSED OFF THE FIELD AS SPECIMEN, CLOSED, PATIENT EXTUBATED, AND TRANSFERRED TO INTENSIVE CARE UNIT IN GUARDED CONDITION. THERE WAS NO PATIENT CONSEQUENCE. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE VASCULAR LINEAR STAPLER - 30 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA E4L53A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR RELOAD-XR30V