BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2233213 · Received September 2, 2011

    Report

    Report Number
    3005075853-2011-01114
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAMMED KNIFE. THE EC60 DEVICE WAS RETURNED WITH THE CLOSING TRIGGER AND ANVIL CLOSED. A RELOAD WAS RECEIVED LOADED ON THE DEVICE AND VOID OF STAPLES; IN ADDITION, THE RELOAD HAD TISSUE AND A CLIP ON THE CARTRIDGE DECK. UPON FURTHER INSPECTION OF THE DEVICE, SEVERAL B-FORMED STAPLES WERE FOUND LODGED IN THE CARTRIDGE KNIFE SLOT PREVENTING THE KNIFE FROM RETURNING COMPLETELY AND THE ANVIL FROM OPENING. WHEN PLACING THE INSTRUMENT ON THE TISSUE TO BE STAPLED, ENSURE THAT NO HARD OBSTRUCTION (SUCH AS A CLIP) IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR WARNINGS AND PRECAUTION REGARDING FIRING ACROSS HARD OBJECTS. THE CLIP WAS REMOVED AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD; THE DEVICE ACHIEVED A COMPLETE 3-STROKES FIRE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE OPENED AND CLOSED AS INTENDED. 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 THE DEVICE WAS STUCK ON THE ANATOMY. THE PHYSICIAN EXPLAINED ALL THAT SHE HAD ATTEMPTED TO DO TO RELEASE THE DEVICE, HOWEVER SHE WAS UNSUCCESSFUL. A REVIEW OF THE STEPS TO RELEASE THE DEVICE WERE DISCUSSED. THE PHYSICIAN ATTEMPTED TO RELEASE AGAIN WITHOUT SUCCESS. NO ADDITIONAL INFORMATION WAS OBTAINED; THE CIRCULATING NURSE HUNG UP. THE CONSEQUENCE TO THE PATIENT IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1