BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO LINEAR CUTTERS - ECHELON

    MDR report key: 3802264 · Received May 9, 2014

    Report

    Report Number
    3005075853-2014-03143
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 15, 2014
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. AN INTRA-OPERATIVE PHOTOGRAPH WAS RECEIVED AND THE VISUAL EVIDENCE INDICATES THE COMPLICATION MAY HAVE BEEN THE RESULT OF ONE OR AN INTERACTION OF SOME COMBINATION OF THE FOLLOWING FACTORS: TISSUE THICKNESS TO CARTRIDGE MISS MATCH, MIGRANT STAPLE PICKED UP BY THE KNIFE, OR CROSSING AN EXISTING STAPLE LINE AT A NON COINCIDENT ANGLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE ECR60D CARTRIDGE RELOAD WAS RECEIVED. THE RELOAD WAS RECEIVED IN GOOD VISUAL CONDITIONS AND FULLY FIRED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOAD. EVENT COULD NOT BE CONFIRMED AS NO DEVICE WAS RETURNED FOR ANALYSIS. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. 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 LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, ON THIRD FIRING OF DEVICE, TISSUE EXTRUDED FROM END OF DEVICE AS BEING PUSHED DURING FIRING, THEN GAINED TRACTION. THE DEVICE WAS OPENED AFTER FIRING AND SURGEON OBSERVED THERE WAS A MALFORMED, INCOMPLETE STAPLELINE AND BLEEDING. THE AMOUNT OF BLEEDING IS UNKNOWN, HOWEVER SURGEON WAS ABLE TO CONTROL BLEEDING BY OVERSEWING STAPLELINE AND NO BLOOD PRODUCTS WERE GIVEN TO PATIENT. THE DEVICE WAS FIRED ON THIRD FIRING ACROSS A PREVIOUSLY PLACED STAPLELINE THAT HAD BEEN CREATED WITH GREEN RELOAD. NO BUTTRESSING MATERIAL WAS USED. THE CASE WAS COMPLETED WITH THIS SAME DEVICE AND NEW RELOADS. THERE WAS NO CHANGE TO PROCEDURE AND NO POST-OP COMPLICATIONS FOR PATIENT ONE WEEK POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280657 ENDO LINEAR CUTTERS - ECHELON STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60D