BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC

    MDR report key: 2133378 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02467
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 26, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE PAN. THE ANALYSIS SHOWED THAT THE ATW35 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. THE DEVICE WAS RECEIVED WITH TWO RELOADS PRESENT. RELOAD B WAS RECEIVED FULLY FIRED AND WITH THE LOCKOUT SPRING NORMAL; RELOAD C WAS RECEIVED PARTIALLY FIRED, WITH THE CARTRIDGE PAN AND THE LOCKOUT SPRING MISSING. THE DAMAGE TO THE CARTRIDGE PAN IS CONSISTENT WITH AN IMPROPER OR INCOMPLETE LOADING/SEATING OF THE CARTRIDGE. IF THE CARTRIDGE IS NOT FULLY INSERTED/SEATED INTO THE CHANNEL, THE RETENTION FEATURES ON THE CARTRIDGE ARE NOT ENGAGED TO THE CHANNEL WINDOWS OF THE DEVICE. AT FIRING THE DEVICE WILL PUSH THE CARTRIDGE FORWARD RESULTING IN THE PAN DISLODGING AND ONLY PART OF THE STAPLES TO BE FIRED AND MALFORMED. IT SHOULD BE NOTED THAT 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THAT THE CARTRIDGES ARE LOADED CORRECTLY. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE CARTRIDGE WAS NOT PROPERLY SEATED BEFORE THE DEVICE WAS FIRED, IT IS POSSIBLE THAT WHILE MANIPULATING THE DEVICES INTO THE TISSUE TO BE STAPLED THE MOST DISTAL PART OF THE CARTRIDGE ENCOUNTERED AN UPWARD FORCE EITHER FROM CONTACT WITH ANOTHER DEVICE OR AN ORGAN RESULTING IN THE CARTRIDGE TO PARTIALLY DISENGAGING FROM THE CHANNEL. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, THE DEVICE WAS USED ON THE PULMONARY ARTERY. THE PULMONARY ARTERY WAS NOT THICK. THE KNIFE MOVED FORWARD TILL THE THREE FOURTHS OF THE STAPLE LINE AND THE STAPLES WERE DEPLOYED TILL THE SAME POSITION AT THE 2ND FIRING. ALSO SOME DEPLOYED STAPLES WERE UNFORMED. ALTHOUGH BLEEDING OCCURRED, IT WAS STOPPED WITH A FORCEPS SOON AFTER. A BLOOD TRANSFUSION WAS NOT REQUIRED. ADDITIONAL SUTURE WAS PERFORMED ENDOSCOPICALLY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WERE NO DIFFICULTIES IN CLOSING AND FIRING THE DEVICE. THE FIRING TRIGGER WAS FULLY GRASPED AT FIRING. REINFORCEMENT PRODUCT WAS NOT USED. AS OF NOW, THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1