BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 2214035 · Received August 17, 2011

    Report

    Report Number
    3005075853-2011-03344
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 28, 2011
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE LONG60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60M CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. IN ADDITION, A PACKAGING TYVEK WAS RECEIVED WITH A COMPLETE STAPLE LINE ON IT. 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. EVENT COULD NOT BE CONFIRMED AS NO STRANGE NOISE WAS HEARD DURING THE ANALYSIS. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A GASTRIC SLEEVE PROCEDURE. THE DEVICE WAS EXTREMELY HARD TO FIRE, RIGHT FROM THE BEGINNING. THE 1ST AND 2ND RELOADS THE STAPLES LINES WERE OK. HOWEVER, THE 3RD RELOAD PARTIALLY WORKED, 1ST AND 2ND STROKE THE STAPLES DEPLOYED NORMALLY, BUT THE 3RD SECTION OF STAPLES FULLY ADVANCED ONLY ON ONE SIDE AND THE CUT LINE WAS COMPLETE, LEAVING A GAP IN THE STAPLE LINE. THIS CAUSED EXCESSIVE BLEEDING, HOWEVER, CLIPS WERE IMMEDIATELY APPLIED AND THE SLEEVE PORTION OF THE CASE WAS COMPLETED. THERE WAS NO BLOOD TRANSFUSION OR ANY OTHER INTERVENTION REQUIRED. ANOTHER DEVICE WAS PULLED AND THE SURGEON ADDED AN ADDITIONAL STAPLE LINE FOR SUPPORT AND THE CASE WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. ON WHAT TISSUE TYPE WAS THE DEVICE USED? STOMACH. AT WHAT LOCATION ON THE TISSUE? ABOVE THE FUNDUS. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? THIRD. DURING WHICH STROKE DID THE EVENT OCCUR? THIRD. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? GREEN. WAS BUTTRESSING MATERIAL UTILIZED? YES IF SO, WHICH PRODUCT? PERI STRIPS. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? YES IF SO, WHEN? ROUGH SOUNDING. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? HIGHER CLOSING AND FIRING. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THE OPERATING ROOM COORDINATOR TEST FIRED THE DEVICE AFTER THE INCIDENT AND REPORTED IT LOCKED OUT ON HER. THE OPERATING ROOM COORDINATOR IS NOT FAMILIAR WITH THIS DEVICE AND SHE MAY NOT HAVE FIRED IT CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H4423R

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G