BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 1981352 · Received February 8, 2011

    Report

    Report Number
    3005075853-2011-00498
    Event Type
    Injury
    Date Received
    February 8, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ANVIL FORMER THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. AFTER FURTHER INSPECTION OF THE ANVIL, THE LOCKING SPRINGS WERE NOTED TO BE SCRATCHED. IT SHOULD BE NOTED THAT TO DETACH THE ANCILLARY TROCAR, IT SHOULD BE ROTATED 45 DEGREES IN THE ANVIL SHAFT SO THAT THE FINGER NOTCHES ARE PERPENDICULAR TO THE LOCKING SPRINGS (UNLOCKED POSITION). UTILIZING THE FINGER NOTCHES, PULL THE ANCILLARY TROCAR OUT OF THE ANVIL SHAFT. DO NOT GRASP THE LOCKING SPRINGS WHEN ATTEMPTING TO DETACH THE ANCILLARY TROCAR. IF THE LOCKING SPRINGS ARE GRASPED, IT WILL LOCK THE ANCILLARY TROCAR INSIDE THE ANVIL AND WOULD RESULT IN DIFFICULTIES TO REMOVE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: EES FIELD QUALITY ENGINEER (FQE) SPOKE TO SURGEON AND REVIEWED WHAT HE HAS EXPERIENCED WITH REMOVING THE BLUE ANCILLARY TROCAR. FQE REVIEWED WITH SURGEON THE MEAN FORCE TO REMOVE THE BLUE VERSUS GREEN, AND NOTED THAT THE DIFFERENCE WAS APPROXIMATELY 8 HUNDREDS OF A POUND. FQE TALKED ABOUT THE POSSIBILITY OF WITHIN SPECIFICATION TOLERANCE STAKE-UPS MAY HAVE CONTRIBUTED TO THE FORCE INCREASE HE EXPERIENCED AS WELL AS REVIEWING SOME OF THE IFU CAUTIONS RELATED TO GRIPPING ACROSS THE CLIPS. SURGEON THEN NOTED THAT HE AND HIS ASSOCIATES ARE VERY FAMILIAR WITH HOW TO USE AND REMOVE THE ANCILLARY TROCAR, AND THAT IN HIS OPINION THERE IS A BAD BATCH OF ANCILLARY TROCARS OUT THERE. FQE NOTED THAT BASED ON OUR BATCH HISTORY RECORDS CHECK, WE HAVE FOUND NOTHING TO INDICATE AN ISSUE. SURGEON WANTED TO BE SURE WE UNDERSTOOD THAT THE SCRAPES WE FOUND DURING ANALYSIS MAY HAVE RESULTED FROM EFFORTS TO REMOVE THE ANCILLARY TROCAR, NOT THE RESULT OF NOT KNOWING HOW TO REMOVE IT.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX EN Y PROCEDURE, PRIOR TO FIRING, THE BLUE ANCILLARY TROCAR COULD NOT BE REMOVED FROM THE ANVIL LAPAROSCOPICALLY AND THE PATIENT HAD TO BE OPENED TO GET IT OUT. SOME TYPE OF GRASPER WAS BEING USED TO REMOVE THE TROCAR. IT SHOULD BE NOTED THAT THE SURGEON IS AN EXPERIENCED USER AND THE LOCKING SPRINGS WERE NOT BEING HELD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH CIR STAPLER CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R