BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 3170705 · Received June 14, 2013

    Report

    Report Number
    3005075853-2013-03037
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 21, 2013
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE STAPLE LINE MISSING ANY STAPLES? ---NO. THE SITUATION IS THAT SOME DEPLOYED STAPLES WERE MALFORMED. WHAT WAS THE APPEARANCE OF THE MALFORMED STAPLES? --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WHERE WAS THE LOCATION OF THE MALFORMED STAPLES ON THE ENDS, THE MIDDLE OF THE STAPLE LINE, THE ENTIRE STAPLE LINE, AND THE ROWS CLOSEST TO THE CUT LINE)? --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WHAT COLOR CARTRIDGE WAS BEING USED? ---GOLD, ECR60D. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. IF BUTTRESSING MATERIAL WAS UTILIZED, WHICH PRODUCT WAS USED? --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. IF ANY UNEXPECTED NOISES WERE HEARD, WHEN WERE THEY HEARD? --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? ---NO. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PNEUMONECTOMY, AT THE 1ST FIRING, THE DOCTOR FELT A SENSE OF DISCOMFORT, AND IT WAS FOUND THAT STAPLES WERE MALFORMED A LOT. THE DEVICE WAS LOCKED OUT AT THE 2ND FIRING. THE DEVICE WAS USED FOR THE LUNG. ANOTHER DEVICE USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271059 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60D