BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2802792 · Received October 24, 2012

    Report

    Report Number
    3005075853-2012-04846
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? MESENTERY. AT WHAT LOCATION ON THE TISSUE? UNK. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? THE 5TH. WHAT COLOR CARTRIDGE WAS BEING USED? WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BLUE. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. 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? YES. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? REVERSE DID NOT WORK, MANUAL OVERRIDE DID NOT WORK, REPLACED DOOR FOR MANUAL OVERRIDE AND KNIFE RETURNED AUTOMATICALLY. WHAT WERE THE PATIENT'S PRE-EXISTING CONDITIONS? DIVERTICULITIS. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? UNK. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE? THREE MONTHS. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO. THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. THE MANUAL OVERRIDE DOOR WAS NOTED TO BE OUT OF POSITION; THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. 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 MANUAL OVERRIDE SYSTEM; 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. THE DEVICE PERFORMED PROPERLY DURING 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 THE DEVICE WAS USED DURING A LAPAROSCOPIC SIGMOID COLECTOMY. ON THE 5TH FIRING THE STAPLES DEPLOYED BUT THE KNIFE BLADE DID NOT RETRACT. THE DEVICE WAS FIRED ON MESENTARY ONLY AND NOT ACROSS A STAPLE LINE. THE SURGEON PUSHED REVERSE BUTTON AND NOTHING HAPPENED. REMOVED BATTERY AND REINSERTED AGAIN NOTHING HAPPENED. REMOVED MANUAL OVERRIDE, RATCHED THE LEVER AND STILL NOTHING HAPPENED. THE DEVICE WAS WIGGLED OFF OF THE TISSUE AND THE DEVICE WAS REMOVE FROM THE PATIENT. THE SCRUB TECH PUT THE MANUAL OVERRIDE DOOR BACK IN PLACE AND THE KNIFE BLADE RETRACTED AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CA7T

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60W