BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 3230341 · Received July 16, 2013

    Report

    Report Number
    3005075853-2013-03588
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE SURGEON, THE PATIENT'S HOSPITAL STAY WAS EXTENDED 48 HOURS FOR PRECAUTIONARY OBSERVATION. THE PATIENT HAS SINCE BEEN RELEASED AND IS DOING GREAT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60G RELOAD PRESENT. THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED; LEFT SIDE OUTER ROW FULLY FIRED AND THE LEFT TWO INNER ROWS PARTIALLY FIRED. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. IN ADDITION, THE DEVICE'S LOCKOUT WAS NOTED TO BE DAMAGED; HOWEVER, THIS CONDITION IS UNRELATED WITH THE EVENT REPORTED. AS ADDITIONAL TESTING, THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. A SURGICAL PHOTOGRAPH WAS RETURNED AND IT IS BELIEVED THAT THIS COMPLICATION WAS POTENTIALLY CAUSED BY THE SLED RAIL HITTING ONE OF THE STAPLE CARTRIDGE INTERNAL TOWERS DAMAGING THE SLED RAIL ENOUGH TO PREVENT THE ASSOCIATED STAPLE DRIVERS FROM BEING LIFTED AND DEPLOYING STAPLES.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 2ND. WHAT IS THE PRODUCT CODE FOR THE DEVICE THAT WAS USED? LONG 60A. YOU STATED THAT THIS WAS A NON-POWERED DEVICE, DURING WHICH STROKE DID THE EVENT OCCUR? 2ND FIRING. THE FIRST FIRING SEQUENCE WAS BAD, SECOND WAS WORSE, THIRD WAS HORRIBLE. HOW MUCH BLOOD WAS LOSS? 40CC (HE USUALLY LOSES 4CC). DID THE PATIENT REQUIRE A BLOOD TRANSFUSION? (NO.) HOW WAS THE TORN TISSUE RESOLVED (WAS THE TORN TISSUE CUT OUT ADDITIONAL TISSUE REMOVED, SUTURED OVER, ECT)? TORN TISSUE WAS SUTURED. WHAT WAS THE APPEARANCE OF THE STAPLES (B-FORMED, IRREGULAR IN SHAPE)? FIRST STAPLE LINE(INNER MOST ROW WAS FORMED), ALL OTHER STAPLE LINES APPEARED NOT EVEN TO FIRE(DID NOT FORM AT ALL.) WHAT WAS THE APPEARANCE OF THE STAPLE LINE (WERE THERE ANY MISSING STAPLES, ROWS MISSING)?INNER MOST ROW FORMED. ALL OTHER STAPLE LINES DID NOT FORM. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? GREEN. IF BUTTRESSING MATERIAL WAS UTILIZED, WHICH PRODUCT WAS USED? GORE. HALF OF A SEAMGUARD ON THE FIRST FIRING, ALL ADDITIONAL FIRINGS WERE WITH SEAMGUARD. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. IF ANY UNEXPECTED NOISES WERE HEARD, WHEN WERE THEY HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? THE ENTIRE FIRING SEQUENCE FELT BAD. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? AFTER THE 2ND FIRING HE OPENED THE GUN AND INSPECTED THE STAPLE LINE. THE FIRST THING NOTICED WAS IT LOOKED LIKE SUTURE WAS ATTACHED TO THE STOMACH. PLEASE NOTE ALL STRINGS OF THE SEAMGUARD WERE PULLED. SURGEON CONFIRMED THAT THE PLASTIC PIECES WERE ALL RETRIEVED FROM THE ABDOMEN DURING THE PROCEDURE. THERE WERE SOME PLASTIC FRAGMENTS WITHIN THE SPECIMEN WHEN IT WAS REMOVED. SURGEON ALSO NOTED THAT THIS ISSUE OCCURED DURING THE THIRD FIRING, NOT THE SECOND FIRING AS PREVIOUSLY REPORTED. DEVICE WAS FULLY ARTICULATED DURING THIS FIRING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE DEVICE WAS FIRED WITH A GREEN CARTRIDGE AND THE PLASTIC ON THE LOAD FRACTURED; IN THE CENTER OF THE PLASTIC PORTION. THE TISSUE TORE AND BLEEDING OCCURRED. THE SURGEON MANUALLY STITCHED THE BLEEDING TISSUE. THERE WERE PATIENT COMPLICATIONS THAT ARE UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329825 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA KACP1H

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G LOT# ASKU