BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 1896918 · Received November 11, 2010

    Report

    Report Number
    3005075853-2010-06443
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 21, 2010
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT B: (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT, AND FORMED THE STAPLES AS INTENDED. THE CARTRIDGE WAS LOADED INTO THE DEVICE WITHOUT ANY DIFFICULTIES AND DID NOT FALL OUT DURING FUNCTIONAL TESTING. THE DEVICE FIRED AS INTENDED, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT. AFTER FURTHER ANALYSIS IT WAS NOTED THAT A RELOAD PAN WAS IN THE DEVICE CARTRIDGE CHANNEL. THE PAN WAS REMOVED AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD; THE DEVICE FIRED, CUT, AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE PAN TO DISLODGE, IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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 AN ANTERIOR RESECTION PROCEDURE, THE SCRUB NURSE REPORTED THAT WHEN LOADING THE FIRST WHITE CARTRIDGE INTO THE DEVICE, THE CARTRIDGE DID NOT FEEL AS IT USUALLY DOES - IT FELT AS THOUGH THE CARTRIDGE WAS TOO TIGHT FOR THE GUN AND IT WAS MORE DIFFICULT TO LOAD THAN USUAL. THE SURGEON NOTED THAT THE GUN WAS MORE DIFFICULT TO INSERT THROUGH THE 12MM TROCAR. THE GUN WAS FIRED OVER VASCULAR TISSUE (IMA). THE STAPLES PROXIMAL TO THE GUN HAD FIRED, BUT THERE WERE NO DISTAL STAPLES AND THERE WAS BLEEDING. THE SURGEON WAS ABLE TO CONTROL THE BLEEDING. IT WAS NOTED THAT THE BLUE DRIVERS FROM THE DISTAL END OF THE STAPLES HAD ACTUALLY COME LOOSE FROM THE CARTRIDGE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE BLEEDING WAS CONTROLLED WITH CLIPS (HEM O LOCK) AND SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TD4C

    Patients

    Seq Age Sex Outcome Treatment
    1