BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3890013 · Received June 24, 2014

    Report

    Report Number
    3005075853-2014-04290
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 30, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT TYPE OF PROCEDURE WAS THE DEVICE USED IN? WHAT COLOR CARTRIDGE WAS BEING USED? DID THE JAWS EVENTUALLY OPEN, WERE THEY FORCED OPEN OR WAS THE DEVICE CUT OFF THE PULMONARY ARTERY? WAS THERE BLEEDING? IF THERE WAS BLEEDING, HOW MUCH BLOOD WAS LOSS? DID THE PATIENT REQUIRE A BLOOD TRANSFUSION? IF YES, HOW MANY UNITS WERE ADMINISTERED? BASED ON THE EVENT DID THE SURGICAL PLAN CHANGE? HOW WAS THE CASE COMPLETED? WAS THE POST-OPERATIVE CARE OF THE PATIENT CHANGED? THE ANALYSIS FOUND THAT ONE EC45A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR45W CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. 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. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE THAT HAS BEEN PARTIALLY FIRED OR FULLY FIRED A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER TO HANDLE IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE BECAME STUCK ON THE PULMONARY ARTERY (ON SEVENTH RELOAD) AND WOULD NOT OPEN. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE PER CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369182 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L90W29

    Patients

    Seq Age Sex Outcome Treatment
    1