BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4222778 · Received November 4, 2014

    Report

    Report Number
    3005075853-2014-07578
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. WHAT OTHER COLOR CARTRIDGES WERE USED AFTER THIS EVENT? WHAT WAS THE PATIENT¿S BMI AND GENDER? WHAT WAS THE PRODUCT CODE AND LOT/BATCH NUMBER FOR THE STAPLER USED WITH THE ECR60T CARTRIDGE (EX, EC60, LONG60A, PSE60A, ETC)? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BASED ON THE PHOTOGRAPHIC EVIDENCE, THE BELIEF IS THAT THE COMPLICATION WAS THE RESULT OF DECK DEFLECTION. THE COMPLICATION WAS THE RESULT OF THE TISSUE WAS BEYOND THE ECR60T (BLACK) STAPLE CARTRIDGES GAP SPECIFICATION AND THE DEVICES ABILITY TO BRING THE CAPTURED TISSUE INTO THICKNESS COMPLIANCE. THE HANDS-ON ANALYSIS RESULTS SHOWED THAT SEVEN CARTRIDGE RELOADS WERE RECEIVED. CARTRIDGE (A, B) L5436J, ECR60T WERE RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITIONS. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF RELOADS (A, B) IN ADDITION FIVE ECR60T CARTRIDGES WERE RECEIVED INSIDE THEIR STERILE PACKAGE. ONE CARTRIDGE WAS PULLED OUT OF ITS STERILE PACKAGE AND LOADED INTO A TEST PLE60A TEST DEVICE. THE DEVICE 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 EVENT COULD NOT BE CONFIRMED AS NO MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE PROCEDURE, THE PHYSICIAN REPORTED THAT THE OUTSIDE ROWS OF THE STAPLES ON THE PATIENT SIDE DID NOT FORM WITH THE BLACK RELOADS. STAPLER WAS USED TO FIRE FOR THE REMAINDER OF THE CASE WITH NO OTHER ISSUES. A COMPETITOR'S DEVICE WITH A BLACK RELOAD WITH TRI-STAPLE WAS USED TO FIRE OVER THE AFFECTED STAPLELINE FROM THE INITIAL FIRINGS WITH BLACK RELOADS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707441 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4F23Z

    Patients

    Seq Age Sex Outcome Treatment
    1