BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3234098 · Received July 18, 2013

    Report

    Report Number
    3005075853-2013-03613
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE ANY STAPLES DEPLOYED ON THE THIRD FIRING PRIOR TO THE DEVICE BEING BLOCKED (LOCKED-OUT)? UNKNOWN. YOU STATED THAT THE MANUAL OVERRIDE ACCESS PANEL MUST BE PRESSED. DID THEY USE THE MANUAL OVERRIDE AND DID THE JAWS OF THE DEVICE OPEN? YES. WAS THE DEVICE FIRED OVER AN EXISTING STAPLE LINE OR CLIP? UNKNOWN. WERE THERE ANY OPENING ISSUES EXPERIENCED WITH THE FIRST AND SECOND FIRINGS? NO. WAS THERE AN INCREASE FORCE TO FIRE WITH ANY OF THE FIRINGS? NO. WERE ANY UNEXPECTED NOISES HEARD? IF YES, WHEN? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH THE MANUAL OVERRIDE DOOR OUT OF POSITION; THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. AN ECR60G WITH THE ONE PIECE SLED PARTIALLY ADVANCED 1/16 WAS PRESENT. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. PLEASE NOTE THAT IF THE INSTRUMENT IS PARTIALLY FIRED, SLIDE THE KNIFE REVERSE SWITCH FORWARD TO RETURN THE KNIFE TO HOME POSITION. TO OPEN THE JAWS, SQUEEZE THE CLOSING TRIGGER, AND THEN SIMULTANEOUSLY PRESS THE ANVIL RELEASE SWITCH ON EITHER SIDE OF THE INSTRUMENT. WHILE PRESSURE IS STILL ON THE ANVIL RELEASE SWITCH, SLOWLY RELEASE THE CLOSING TRIGGER. IT SHOULD BE NOTED AFTER THE MANUAL OVERRIDE SYSTEM IS USED THE INSTRUMENT IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENCE FIRINGS. THE DEVICE WAS DISASSEMBLED TO RESET THE BAILOUT SYSTEM AND THEN, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. THE REVERSE KNIFE FEATURE WORKED AS INTENDED. 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 GASTRIC SLEEVE PROCEDURE, AFTER THE THIRD RELOADING THE INSTRUMENT COULD NOT BE OPENED. THE MOTOR GOT ON AND BLOCKED, THE MANUAL OVERRIDE ACCESS PANEL MUST BE PRESSED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336412 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CT28

    Patients

    Seq Age Sex Outcome Treatment
    1