BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 1822020 · Received September 1, 2010

    Report

    Report Number
    3005075853-2010-04914
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 5, 2010
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE (B)(4) DEVICE WAS RECEIVED WITH NO VISUAL NON-CONFORMANCES AND WITH A GREEN CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED AND WAS NOTED TO HAVE DAMAGE ON THE CARTRIDGE RELOAD DECK. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND FIRED WITHOUT ANY DIFFICULTIES NOTED AND THE STAPLES WERE NOTED TO HAVE THE APPROPRIATE B-FORM SHAPE. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE MAY BE IF THE DEVICE WAS INADVERTENTLY CLAMPED OVER A HARD OBJECT SUCH AS A CLIP OR OTHER SURGICAL DEVICE. 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. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON WAS USING THE STAPLER ACROSS THE BOWEL LAPAROSCOPICALLY. NEEDED A SECOND FIRING TO GET ACROSS, UPON FIRING THE RELOAD THE SURGEON REPORTED THAT THE HANDLE FELT STRANGE, HARDER TO FIRE THAN USUAL AND THE STAPLES DIDN`T FORM AT ALL. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER STATES THAT HE ATTEMPTED TO TEST ON HIS AVIVA METER, AND RECEIVED AN ERROR OF E-1, WHEN HE FELT SICK. CUSTOMER DROVE HIMSELF TO THE HOSPITAL, WHERE HE WAS TESTED AT 60 MG/DL ON THE HOSPITAL'S METER. CUSTOMER WAS NOT TREATED AT THAT TIME AND MADE TO REMAIN IN THE ER WAITING AREA. CUSTOMER BEGAN TO GO INTO DIABETIC SHOCK/CONVULSIONS. CUSTOMER WAS THEN TREATED WITH JUICE AND FOOD AND WAS FEELING BETTER ABOUT 20 MINUTES AFTER THE TREATMENT. CUSTOMER WAS NOT ADMITTED TO THE HOSPITAL, BUT REMAINED IN THE ER THE MAJORITY OF THE DAY. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4T442

    Patients

    Seq Age Sex Outcome Treatment
    1