BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2253429 · Received September 19, 2011

    Report

    Report Number
    3005075853-2011-03858
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, DURING THE FINAL FIRING, THE DEVICE WAS FIRED ACROSS THE SMALL BOWEL. UPON OPENING THE DEVICE THE STAPLES DID NOT FORM IN THE MIDDLE OF THE STAPLE LINE AND THE LUMEN OF THE BOWEL WAS VISIBLE. THE SURGEON WAS USING A WHITE RELOAD ACROSS THE BOWEL. THE CLOSED THE LUMEN WITH SUTURE TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE DEVICE WAS DISPOSED. ADDITIONAL FOLLOWUP: DURING WHICH STROKE DID THE EVENT OCCUR? AS NOTED IN THE COMPLAINT, THE STAPLES DID NOT FORM CORRECTLY IN THE MIDDLE OF THE STAPLE LINE. THIS WAS NOTICED AFTER THE DEVICE WAS REMOVED FROM THE TISSUE. I AM ESTIMATING THIS OCCURRED DURING THE 2ND STROKE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BLUE WAS USED BEFORE. NOTHING WAS USED AFTER AS THIS WAS THE FINAL FIRING. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO.

    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