BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2182965 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03069
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 7, 2011
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RETURNED THE ANALYSIS RESULTS SHOWED THAT FIVE ECR60B CARTRIDGE RELOADS WERE RECEIVED. THE RELOADS WERE RECEIVED IN GOOD VISUAL CONDITIONS AND FULLY FIRED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOADS. EVENT COULD NOT BE CONFIRMED AS NO DEVICE WAS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BY PASS PROCEDURE WITH A LONG DEVICE WHEN THE SURGEON FIRED THE DEVICE FOR THE NINTH FIRING AND BEGAN TO SUTURE HE NOTICED THAT THE STAPLES WERE STRAIGHT LEGGED AND MALFORMED. HE THEN COMPLETED WITH SUTURE OVER THE STAPLE LINE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS DISCARDED BUT THE RELOADS ARE AVAILABLE FOR RETURN. THEY ARE RETURNING ALL OF THE RELOADS THEY HAVE DUE TO THEY ARE UNSURE WHICH ONE DID NOT FIRE CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60B