BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45

    MDR report key: 2963210 · Received February 15, 2013

    Report

    Report Number
    3005075853-2013-00634
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 21, 2013
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? FIRST FIRING. DURING WHICH STROKE DID THE EVENT OCCUR? FOURTH. HOW WAS THE DAMAGED TISSUE RESOLVED? EVICEL. DID THE DEVICE START TO DEPLOY STAPLES AND CUT AND THEN STOP? NO. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES. POSSIBLY A BULLDOG CLIP. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. WHAT IS THE CURRENT STATUS OF THE PATIENT? STABLE. PATIENT RECOVERED WELL AND EVICEL WAS USED. THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR45W CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. 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 THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED AND THE KNIFE REVERSE BUTTON WORKED AS INTENDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? DURING WHICH STROKE DID THE EVENT OCCUR? HOW WAS THE DAMAGED TISSUE RESOLVED? DID THE DEVICE START TO DEPLOY STAPLES AND CUT AND THEN STOP? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? WHAT IS THE CURRENT STATUS OF THE PATIENT? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LIVER RESECTION PROCEDURE, SURGEON WAS REMOVING PART OF LIVER BY STAPLING ACROSS WHEN GUN JAMMED, REVERSE KNIFE WOULD NOT WORK, GUN WOULD NOT UNLOCK, HE HAD STAPLED ON TOP OF BULLDOG CLIP. NEEDED TO RIP GUN OFF TISSUE. PROCEDURE WAS PROLONGED 30 MINUTES. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE. NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68828 ECHELON*FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H44Z1V

    Patients

    Seq Age Sex Outcome Treatment
    1