BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2840306 · Received November 20, 2012

    Report

    Report Number
    3005075853-2012-05288
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ELEVEN RELOADS WERE RECEIVED INSTEAD OF THE REPORTED LONG60A. THE RELOADS WERE RECEIVED IN GOOD CONDITION. RELOADS A, B, C, D, E, F AND G WERE RECEIVED FULLY FIRED; RELOADS H, I, AND J WERE RECEIVED UNFIRED; RELOADS K AND L WERE RECEIVED STERILE. THE RETURNED RELOADS I, K, AND L WERE 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 SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. BATCH J5HZ8V MANUFACTURED DATE: 08/30/2012; PRODUCT EXP. DATE: 07/30/17. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DURING A LAPAROSCOPIC GASTRIC BYPASS, ROUX EN Y WHEN CONNECTING THE GASTRIC TO JEJUNOSTOMY NO STAPLES WERE PRESENT ON THE DISTAL SIDE(ROUX LIMB TIP) OF THE CUT LINE AND COMPLETELY TRANSECTED. NO MALFORMED STAPLES WERE VISIBLE ON THE PROXIMAL SIDE WERE SEEN. THE DEVICE WAS THEN RELOADED WITH ANOTHER WHITE LOAD RELOAD, SOME OF THE STAPLES DURING THE SECOND STROKE DID NOT FORM AT ALL AND THE STAPLES ON THE FIRST AND THIRD WERE PARTIALLY FORMED. JJ - LINE INSPECTED BUT SURGEON WAS CONCERNED ABOUT POST OP ISSUES. NO PATIENT CONSEQUENCES, PATIENT DOING WELL. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? NO. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT?NONE USED. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP?NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN?NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)?NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE?NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS, ROUX EN Y PROCEDURE, THE SURGEON WAS COMPLETING THE ROUX LIMB GASTROJEJUNOSTOMY AND NOTICED THE ROUX LIMB WIDE OPEN FROM EARLIER TRANSACTION. THE SURGEON PULLED SECOND RELOAD AND FIRED. ALL STAPLES MALFORMED AND THE SURGEON THEN HAD TO CLOSE THE ROUX TIP WITH SUTURE. THERE WERE NO PATIENT CONSEQUENCES. THE SURGEON WAS ABLE TO CONTINUE TO USE ECHELON GUN WITH RELOADS. CLOSED TISSUE WHERE PROBLEM OCCURRED WITH SUTURE. COMPLETED LEAK TEST WITHOUT ANY NOTICED LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA JACA79

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60W