BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 45MM

    MDR report key: 3242368 · Received July 23, 2013

    Report

    Report Number
    3005075853-2013-03675
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 26, 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 Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. PREMATURE SLED MOVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? COLON. AT WHAT LOCATION ON THE TISSUE? WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ASKU. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? 5TH. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BLUE. WAS BUTTRESSING MATERIAL UTILIZED? NO IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES. WERE ANY UNEXPECTED NOISES HEARD? YES IF SO, WHEN? DURING FIRING. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? MANUALLY. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? NO. THE ANALYSIS FOUND THAT DEVICE (A) 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 ECR60B WITH THE ONE PIECE SLED PARTIALLY ADVANCED WAS LOADED ON THE DEVICE. 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; NO ABNORMAL NOISE WAS NOTED. THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. THE REVERSE BUTTON WORKED AS INTENDED. EVENT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED DURING THE FUNCTIONAL TESTING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS FOUND THAT DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE LOADED ON THE DEVICE. THE DEVICE 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; NO ABNORMAL NOISE WAS NOTED. THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. THE REVERSE BUTTON WORKED PROPERLY. EVENT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED DURING THE FUNCTIONAL TESTING. 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 LAPAROSCOPIC COLON RESECTION THE DEVICE FIRED FOUR TIMES WITH BLUE RELOAD AND HAD NO ISSUES. WHEN THE SURGEON FIRED THE 5TH FIRING WITH A BLUE CARTRIDGE IT PARTIALLY FIRED AND THEN STOPPED. IT THEN MADE AN UNUSUAL NOISE AND WOULD NOT POWER TO WORK WITH THE REVERSE BUTTON. THEY THEN USED THE MANUAL RELEASE AND IT REVERSED AND WAS REMOVED FROM THE TISSUE. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343972 PWRD ECH FLEX 45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1