BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2963786 · Received February 15, 2013

    Report

    Report Number
    3005075853-2013-00647
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. PREMATURE SLED MOVEMENT, DAMAGED JOINT COVER. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HAS ADDITIONAL TISSUE TO BE CUT OUT? IF YES, PLEASE SPECIFY THE AMOUNT OF ADDITIONAL TISSUE IN CM, OR WAS THIS TISSUE INTENDED TO BE CUT AWAY ANYWAY? IT WAS TO BE CUT OUT ANYWAY. HAS THIS ANY IMPACT ON THE PATIENT, THE SURGERY OR THE HEALING PROCESS? NONE. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? BOWEL. WAS IT USED ON THICK TISSUE? NO. DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? DO NOT KNOW. WAS THE CARTRIDGE CORRECT INSERTED, DID THEY HEAR THE "CLICK"? YES. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? SECOND. DURING WHICH STROKE DID THE EVENT OCCUR? FIRST. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NEXT TO GIA LINE. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NOT DURING FIRING. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? OPENING, AS IT WOULDN'T. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? NO. THE EC60A DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR60D CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED (B)4). 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. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE THAT HAS BEING PARTIALLY FIRED OR FULLY FIRED A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER TO HANDLE IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. THE RETURNED DEVICE AND CARTRIDGE RELOAD WERE TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE STROKE 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 EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED AS INTENDED; THE KNIFE REVERSE BUTTON PERFORMED PROPERLY. 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 LOW ANTERIOR RESECTION OF THE BOWEL AND ENDOGIA WAS USED TO TRANSECT, BUT THIS PERFORATED THE BOWEL. THE ECHELON FLEX WAS USED TO REPAIR THIS WHILST THE ENDOGUA WAS IN PLACE. WITH THE FIRST FIRING WITH A BLUE CARTRIDGE IT CUT AND STAPLED PERFECTLY. THE DEVICE WAS THEN RELOADED AND THIS IS WHEN LOCK-OUT OCCURRED ON THE FIRST FIRING. THEY COULD NOT OPEN THE JAWS AND HAD TO USE THE ENDO GIA TO CUT THE DEVICE OUT OF THE PATIENT. THEN AFTER REMOVAL THEY MANAGED TO OPEN THE JAWS, BUT WERE NOT SURE HOW. WHEN I ASKED IF THEY REVERSED THE RED BUTTON, THEY SAID YES, HOWEVER DID NOT SEEM SURE TO HAVE ACTIVATED THE HANDLE TO PULL THE BLADE BACK. THERE WAS A NOISE WHEN THE RED BUTTON WAS USED. IT WAS NOTED THAT THE PELVIS WAS UNUSUALLY NARROW. IT WAS NOT FIRED ACROSS A STAPLE LINE AND THE TISSUE WAS NOT UNUSUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68764 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1