BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2083536 · Received May 10, 2011

    Report

    Report Number
    1527736-2011-00111
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. JAMMED KNIFE. THE ANALYSIS FOUND THAT THE EC60A DEVICE WAS RECEIVED WITH THE KNIFE JAMMED AND WITH A GREEN CARTRIDGE RELOAD PRESENT. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITIONS OF THE INTERNAL COMPONENTS AND NO ANOMALIES WERE FOUND ON THE HANDLE. AFTER FURTHER ANALYSIS OF THE TUBE THE KNIFE WAS NOTED TO BE JAMMED AND NICKED. IN ADDITION, SEVERAL B-FORM STAPLES WERE NOTED LODGED BETWEEN THE KNIFE AND THE ANVIL CHANNEL, RESULTING IN THE FIRING MECHANISMS JAMMING. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WEDGE RESECTION PROCEDURE, THE DEVICE LOCKED ON LUNG TISSUE AND THEY COULD NOT GET IF OFF. THEY HAD TO PRY THE JAWS OPEN TO GET IT OFF THE TISSUE. A NEW DEVICE WAS PULLED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT. IT IS UNCERTAIN IF THE DEVICE WAS RETAINED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1