BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RELOAD FOR ECHELON 60

    MDR report key: 8247771 · Received January 15, 2019

    Report

    Report Number
    3005075853-2019-15932
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Date of Event
    November 28, 2018
    Report Date
    December 17, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001775
    PMA / PMN Number
    K051002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). BATCH NUMBER: R57Y6K. INVESTIGATION SUMMARY: THE ANALYSIS RESULTS SHOWED THAT ONE ECR60B RELOAD WAS RECEIVED PARTIALLY FIRED 1/16. THE RETURNED RELOAD WAS RESET AND LOADED INTO A TEST DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION AND 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. 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. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH/LOT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. CAN YOU PLEASE CLARIFY WHAT WAS MEANT BY, ¿WITH OPENING OF THE ENTIRE STAPLED AREA¿? WHAT WAS THE APPEARANCE OF THE DEPLOYED STAPLES (B-FORMED, MALFORMED, GOAL POST/LEGS STRAIGHT)? WERE THERE STAPLES MISSING FROM THE STAPLE LINE? HOW WAS THE STAPLE AREA REPAIRED? WHAT WAS MEANT BY, ¿WE NEED TO MAKE MANUAL RAFFIA FOR BEING A SLEEVE WITH NO SPACE FOR NEW STAPLERS¿? WAS THE TISSUE OVERSEWN WITH SUTURE? DID THE REPAIR ALTER THE PROCEDURE IN ANY WAY? WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT (EXTENDED HOSPITAL STAY, READMISSION, REOPERATION, ETC.)? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WE HAD A COMPLETE FAILURE OF STAPLING IN THE PENULTIMATE STAPLE WITH OPENING OF THE ENTIRE STAPLED AREA. THE SYSTEM WAS ECHELON POWER AND THE RELOAD USED FOR BODY AND BOTTOM TRANSITION REGION WAS BLUE AS PER MANUFACTURER'S RECOMMENDATION. WE NEED TO MAKE MANUAL RAFFIA FOR BEING A SLEEVE WITH NO SPACE FOR NEW STAPLERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44357 BLUE RELOAD FOR ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. R40F02 10705036001775

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR