BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE LINEAR STAPLER

    MDR report key: 4213654 · Received October 30, 2014

    Report

    Report Number
    3005075853-2014-07488
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE SALES REP WAS PRESENT FOR THE CASE. WHILE THE SALES REP WAS OBSERVING THE PROCEDURE, HE DID NOT THINK THE PIN WAS FULLY SEATED AS THE RETAINING PIN KNOB DID NOT SEEM TO BE ALL THE WAY FORWARD. HE ASKED THE SURGEON PRIOR TO FIRING IF THE PIN WAS SEATED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT IS THE PATIENT¿S CURRENT CONDITION? WHAT WERE THE PATIENT¿S PRE-OP DIAGNOSIS AND/OR PRE-EXISTING CONDITIONS THAT COULD HAVE IMPACTED THE PATIENT¿S HEALTH/SURGICAL OUTCOME? WERE ANY DIFFICULTIES ENCOUNTERED WHEN CLOSING ON THE TISSUE? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WHERE IN THE GREEN ZONE WAS THE DEVICE FIRED? THE ANALYSIS RESULTS SHOWED THAT THE TLH90 DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RETURNED VOID OF STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT CYCLED, FIRED, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT LOWER LOBECTOMY VATS PROCEDURE, ON THE FOURTH FIRING OVER THE PULMONARY ARTERY AND PULMONARY VEIN, THE DEVICE WAS FIRED AND THE STAPLES DID NOT HAVE ANY FORMATION AS THE STAPLES DID NOT HIT THE POCKETS DURING FIRING. THE SURGEON FELT THE PIN WAS SEATED PROPERLY PRIOR TO FIRING. THE SURGEON HAD ALREADY CUT THE TISSUE BEFORE THIS ISSUE WAS NOTED. APPROXIMATELY, TWO LITERS OF BLOOD LOSS WAS NOTED. THE PATIENT'S BLOOD PRESSURE DROPPED TO 42/24MMHG. THE CELL SAVER WAS USED AND FIVE UNITS OF BLOOD, TWO FRESH FROZEN PLASMA (FFP), AND ONE PLATELET WERE GIVEN TO THE PATIENT. THE BLOOD PRESSURE INCREASED AFTER THE ADMINISTRATION OF BLOOD PRODUCTS. THE BLEEDING WAS CONTROLLED WITH SUTURE. THE PROCEDURE WAS PROLONGED BY TWO HOURS DUE TO THE INCIDENT. IT WAS NOTED THERE WAS POOR VISIBILITY DURING THE CASE AND THE TISSUE WAS THICK. THE PATIENT IS DOING WELL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696148 PROXIMATE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4D78Y

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR