BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2173013 · Received July 23, 2011

    Report

    Report Number
    3005075853-2011-02942
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL FOLLOWUP: THE PATIENT WAS AN (B)(6) FEMALE WITH A VERY LARGE SPLEEN. WHEN SPEAKING WITH THE ASSISTANT SURGEON ABOUT PATIENT IN THE ICU ON (B)(6) 2011, SHE WAS DOING FINE. WHEN SURGEON WAS ASKED WHY THE CONVERT TO OPEN; WAS IT THE PATIENT'S SPLEEN SIZE OR THE BLEEDING. THE SURGEON STATED THE BLEEDING. THE REP RECEIVED A MESSAGE FROM NURSE CIRCULATOR AND STATED THE DEVICES WERE BEING HELD FOR HER TO PICK UP AND RETURN FOR EVALUATION. THE NURSE ALSO REQUESTED INSTRUCTIONS ON OPENING THE DEVICE. THIS WAS FOR VERIFICATION OF THE OPENING SEQUENCE. WHEN REP WAS TO RETRIEVE THE DEVICES, SHE WAS ADVISED THE DEVICES HAD BEEN DISCARDED. NOT SAVED AS ORIGINALLY REPORTED. NO LOT/BATCH INFORMATION WAS KNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC SPLENECTOMY. THE FIRST DEVICE 60MM WAS USED ON THE SPLENIC VESSELS. THE DEVICE WAS RELOADED TWICE AND WORKED AS INTENDED. ON THE 3RD RELOAD, 1ST AND 2ND STROKES WERE COMPLETED, HOWEVER ON THE 3RD STROKE THE DEVICE WOULD NOT FIRE AND WOULD NOT OPEN. THE ASSISTING SURGEON PUSHED THE RED BUTTON, PULLED THE TRIGGER FORWARD AND THE DEVICE OPENED AND REMOVED FROM THE VESSEL. THE SECOND DEVICE 45MM WAS PULLED TO COMPLETE THE CASE. THE 45MM WAS RELOADED TWICE AND WORKED AS INTENDED. ON THE 3RD RELOAD, 1ST AND 2ND STROKES WERE COMPLETED, HOWEVER ON THE 3RD STROKE THE DEVICE WOULD NOT FIRE AND WOULD NOT OPEN, AGAIN. THE ASSISTING SURGEON COMPLETED THE SAME STEPS AS THE FIRST DEVICE TO REMOVE THE DEVICE FROM THE VESSEL. A THIRD DEVICE, 45MM WAS OPENED AND WORKED PROPERLY. THERE WAS TISSUE DAMAGE, BUT IT IS UNKNOWN WHICH DEVICE MAY HAVE CAUSED THE DAMAGE. THE PATIENT REQUIRED A TRANSFUSION OF APPROXIMATELY 3 UNITS OF BLOOD. THE CASE WAS CONVERTED TO AN OPEN PROCEDURE. THE CASE WAS COMPLETED WITH A COMPETITOR CLIP APPLIER. IT WAS STATED THAT THE SCRUB TECH DID NOT PRELOAD THE APPLIER, SO WHEN IT CLAMPED DOWN ON THE STAPLE LINE BLEEDING AREA WITH NO CLIP IN JAW, IT STOPPED THE BLEEDING. THE CASE WAS COMPLETED WITH A COMPETITOR'S APPLIER AND LIGATED THE VESSEL. THE PATIENT WAS PLACED IN ICU. THE DEVICES WERE DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention ECR60M