BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX60

    MDR report key: 1874498 · Received October 18, 2010

    Report

    Report Number
    3005075853-2010-05899
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO 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 NO CARTRIDGE RELOAD LOADED ON THE DEVICE. 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. 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 DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE ON THE FOURTH FIRING ON THE SMALL BOWEL WITH A WHITE LOAD, THE STAPLES WERE J-SHAPED ON THE LEFT SIDE AT THE MIDDLE AND DISTAL PORTION OF THE STAPLE LINE. THE DEVICE WAS RELOADED FOR THE FIFTH FIRING WITH A WHITE LOAD AND THE STAPLE LINE WAS COMPLETE. THE DEVICE WAS RELOADED FOR THE SIXTH FIRING WITH A WHITE LOAD THE STAPLES WERE J-SHAPED ON THE LEFT SIDE AT THE MIDDLE AND DISTAL PORTION OF THE STAPLE LINE. THE SIXTH FIRING WAS ACROSS A STAPLE LINE. SUTURES WERE USED TO OVER SEW THE STAPLE LINE. THERE WAS NO PT CONSEQUENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE PROXIMAL RIGHT CORONARY ARTERY A 3.0X28 RX PROMUS STENT WAS IMPLANTED. A GRADE F DISSECTION OCCURRED DISTAL TO THE TARGET LESION. THE DISSECTION WAS TREATED WITH THE PLACEMENT OF TWO ADDITIONAL RX PROMUS STENTS, A 3.0 X 12 MM AND A 3.0 X 28 MM. FOLLOWING POST-DILATATION, THERE WAS 0% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED ON (B)(6) 2009 WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. PER PHYSICIAN, THE RELATIONSHIP OF THE ADVERSE EVENT TO THE INDEX PROCEDURE IS HIGHLY PROBABLE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON FLEX60 GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA G4TM4G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK