BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2963941 · Received February 15, 2013

    Report

    Report Number
    3005075853-2013-00664
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 28, 2013
    Report Date
    January 24, 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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCORRECT CARTRIDGE SIZE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? IT WAS THE VERY FIRST FIRING. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE THIS EVENT? NO OTHER STAPLER HAD BEEN USED. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO BUTTRESSING MATERIAL USED. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO OTHER STAPLE LINE OR CLIPS ON THE LUNG TISSUE. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? DON'T REMEMBER ABOUT A NOISE. WAS THERE ANY DAMAGE TO THE TISSUE ONCE THE DEVICE WAS OPENED? IF YES, HOW WAS THE DAMAGE TISSUE TAKEN CARE OF? NO DAMAGE TO LUNG TISSUE. PLEASE EXPLAIN HOW OR WHAT WAS USED TO PRY THE JAWS OF THE DEVICE OPEN? THE SURGEON USED HIS HANDS TO PRY OPEN THE JAWS. WHAT IS THE CURRENT STATUS OF THE PATIENT? HAVE NO IDEA OF CURRENT PATIENT CONDITION. 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 ECR45G CARTRIDGE RELOAD WAS PRESENT. THE CARTRIDGE WAS RECEIVED UNFIRED. IT SHOULD BE NOTED THAT A 60MM DEVICE IS DESIGNED TO WORK ONLY WITH 60MM CARTRIDGES, FOR FURTHER LOADING INSTRUCTIONS PLEASE REFER TO THE ECHELON FLEX 60 POWERED IFU. PLEASE NOTE THAT IF THE REVERSE SWITCH DOES NOT RETURN THE KNIFE TO HOME POSITION THE JAWS WILL NOT OPEN. ENSURE THAT THE BATTERY PACK IS SECURELY INSTALLED AND THE INSTRUMENT HAS POWER AND THEN, TRY THE KNIFE REVERSE SWITCH AGAIN. IF THE KNIFE DOES NOT RETURN, USE THE MANUAL OVERRIDE. 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. IN ADDITION, PLEASE NOTE 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. 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 THORACOTOMY WITH LOBECTOMY, THE DEVICE WOULD NOT OPEN AND THE TISSUE COULD NOT BE RELEASED. THE MANUAL RELEASE BUTTON DID NOT WORK. THE JAWS WERE PHYSICALLY PRIED OPEN AND THE TISSUE WAS RELEASED. IT IS UNKNOWN HOW OR WHAT WAS USED TO PRY THE JAWS OPEN. THE COLOR OF THE CARTRIDGE WAS GREEN. IT IS UNKNOWN IF BUTTRESSING MATERIAL WAS USED. IT IS UNKNOWN WHAT FIRING THE ISSUE OCCURRED ON. THE CASE WAS COMPLETED USING A DIFFERENT VENDOR'S STAPLER. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68003 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4C93E

    Patients

    Seq Age Sex Outcome Treatment
    1