BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2111831 · Received June 2, 2011

    Report

    Report Number
    3005075853-2011-02249
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 25, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADDITIONAL INFORMATION. EES FIELD QUALITY ENGINEER REVIEWED THE TWO X-RAYS ON (B)(4) 2011. BASED ON THE WHAT COULD BE CLEARLY OBSERVED IN THE TWO X-RAYS, I COULD NOT IDENTIFY ANY MALFORMED STAPLES. ALL STAPLES APPEAR TO HAVE ACCEPTABLE "B" FORM AS COULD BE OBSERVED. HENCE, NO POSSIBLE REASON FOR THE DESCRIBED EVENT COULD BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE. WHEN FIRING A WHITE RELOAD OVER SMALL BOWEL THE 2ND STROKE OF FIRING SEQUENCE RESULTED IN MALFORMED STAPLES. THE AREA WAS OVER SEWN AND THE CASE WAS COMPLETED. THE SAME DEVICE WAS USED DURING THE CASE WITH DIFFERENT RELOADS AND ALL FIRINGS WORKED FINE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE DEVICE WAS DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)