BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER

    MDR report key: 4940213 · Received July 24, 2015

    Report

    Report Number
    3005075853-2015-04589
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 5, 2015
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RESULTS - INCOMPLETE CYCLE. BATCH# L53L7X. THE ANALYSIS RESULTS FOUND THAT THE ATW45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A TR45W CARTRIDGE LOADED ON THE DEVICE. THE RETURNED RELOAD WAS PARTIALLY FIRED WHICH INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE DEVICE WOULD NOT FIRE AND WAS DIFFICULT TO CLOSE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482460 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK L4EZ4H

    Patients

    Seq Age Sex Outcome Treatment
    1