BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE LINEAR STAPLER

    MDR report key: 3896932 · Received June 26, 2014

    Report

    Report Number
    3005075853-2014-04434
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: RECEIVED ADDITIONAL INFORMATION FROM THE AFFILIATE: WAS THERE A PROXIMAL AND DISTAL CONTROL PLACED ON THE VESSEL? YES. DID THE SURGEON INSPECTED THE STAPLE LINE AFTER RELEASING THE DEVICE AND PRIOR TO DIVING THE VESSEL? NO, BECAUSE THERE WAS MASS BLEEDING. WAS A TRANSFUSION REQUIRED? HOW MUCH UNITS? YES, 3 UNITS (1 LITER APPROXIMATELY) DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. DID THIS EVENT HAPPENED WITH THE ORIGINAL CARTRIDGE OR AFTER RELOADING? ORIGINAL CARTRIDGE. IF THE DEVICE WAS RELOADED: -HOW MANY TIMES? 0. -WAS THE CARTRIDGE CORRECT INSERTED, DID THEY HEAR THE ¿CLICK¿? - ¿NO CLIPS WERE FORMED ON THE TISSUE¿ WERE THEY MISSING, UNFORMED , MALFORMED, PLEASE DESCRIBE THE SHAPE. THERE WERE MISSING. WHAT IS THE AGE OF THE PATIENT? (B)(6) YEARS OLD. WHAT IS THE CURRENT STATUS OF THE PATIENT AND IS HE EXPECTED TO HAVE A FULL RECOVERY? EXCELLENT STATUS- HE STAYED IN THE INTENSIVE CARE UNIT 24HR AND DISCHARGED FROM THE HOSPITAL ON THE 8TH POST-OPERATIVE DAY. ADDITIONAL INFORMATION REQUESTED: WERE THE STAPLES IDENTIFIED IN THE SURGICAL FIELD? WAS THE VESSEL TRANSECTED PRIOR TO INSPECTION OF THE STAPLE LIVE? WERE ANY MALFORMED STAPLED IDENTIFIED OR NOT PRESENT? WAS THE DEVICE DIFFICULT TO FIRE? WERE THERE ANY TISSUE LOADING DIFFICULTIES? ANY RETENTION ISSUES? WAS A DIFFERENT DEVICE USED ON THE BRONCUS PRIOR TO USING THE TX30V?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS SHOWED THAT THE TX30V DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLES WERE NOTED TO HAVE A PROPER B-FORMATION AND THE STAPLE LINE WAS COMPLETE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACOTOMY- LOBECTOMY PROCEDURE, AFTER CUTTING AND SEALING BRONCHUS, THE SURGEON USED DEVICE ON PULMONARY VEIN. AFTER OPENING THE JAWS NO CLIPS WERE FORMED ON THE TISSUE. THIS CAUSED SEVERE BLEEDING, COMING RIGHT FROM THE HEART, BECAUSE THE LENGTH OF THE VEIN WAS VERY SHORT. HE USED HIS HANDS AND CLAMPS TO STOP THE BLEEDING AND AFTER A FEW MINUTES HE MANAGED TO CONTROL THE PROBLEM. SUTURES WERE USED TO STOP SEVERE BLEEDING FROM THE PULMONARY VEIN. THESE SUTURES WERE ATTACHED TO THE HEART DUE TO SHORT TISSUE LENGTH. THE PATIENT IS MALE AND LOST ABOUT 1-1.5 LITERS OF BLOOD DURING BLEEDING. AFTER THE SURGERY HE WAS ENTERED TO THE INTENSIVE CARE UNIT. HE HAS TO STAY 1 OR 2 DAYS LONGER IN INTENSIVE CARE UNIT DUE TO THIS INCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374745 PROXIMATE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4D82P

    Patients

    Seq Age Sex Outcome Treatment
    1