BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 45 ENDOPATH

    MDR report key: 3152906 · Received June 8, 2013

    Report

    Report Number
    3005075853-2013-02879
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. LOT# J4AE98 BELONGS TO AN EC45A AND EVENT DESCRIPTION READS THE SAME, PLEASE CONFIRM THAT A EC45A WAS USED. WAS THE CARTRIDGE CORRECT INSERTED, DID THEY HEAR THE ¿CLICK¿? WAS IT USED ON THICK TISSUE? DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? WAS THE DEVICE FULLY ARTICULATED? DEGREE OF ARTICULATION? WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? HAS ADDITIONAL TISSUE TO BE CUT OUT? IF YES, PLEASE SPECIFY THE AMOUNT OF ADDITIONAL TISSUE IN CM? HAS THIS ANY IMPACT ON THE PATIENT, THE SURGERY OR THE HEALING PROCESS? SINCE THERE WAS BLEEDING, IS IT POSSIBLE THAT THE PATIENT¿S HEALTH HISTORY OR ANATOMY CONTRIBUTED TO THE DIFFICULTIES THAT WERE ENCOUNTERED? WAS A TRANSFUSION REQUIRED? WAS THE PATIENT TAKING ANY ANTICOAGULANTS? IF YES, SPECIFY PRESCRIBED MEDICATION. DOES PATIENT HAVE A KNOWN COAGULATION DISORDER? HAS THE PATIENT TAKEN ANY STEROIDS? WHAT WAS THE PATIENT¿S PRE-OP HEMOGLOBIN AND HEMATOCRIT? WHAT WAS THE PATIENT¿S POST OPERATIVE HEMOGLOBIN AND HEMATOCRIT? HOSPITALIZATION EXTENDED? HOW MUCH ADDITIONAL TIME? WHAT IS THE AGE AND SEX OF THE PATIENT? WHAT IS THE CURRENT STATUS OF THE PATIENT? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE?

    Additional Manufacturer Narrative · 1

    (B)(4). : ADDITIONAL INFORMATION PER THE ACCOUNT MANAGER, "PLEASE BE ADVISED I MET WITH MR. (B)(6) TODAY FOLLOWING UP ON COMPLAINT REF: (B)(4). THE SURGEON HAS ADVISED ME THE PATIENT DIED FROM AIRWAY/NEUROLOGICAL DISEASE. THE PATIENT HAS A HISTORY OF ISSUES WITH ANESTHESIA DURING PREVIOUS PROCEDURES AND DIRECTLY FOLLOWING THE PROCEDURE EXPERIENCED LAPSES OF CONSCIOUSNESS. THE SURGEON DOES NOT BELIEVE THAT THE ISSUE WITH THE DEVICE IS RESPONSIBLE FOR THE DEATH OF THE PATIENT, THE SURGEON AND THE CLINICIANS CARING FOR THE PATIENT HAVE CONFIRMED THAT THE PATIENT DIED OF AIRWAY/NEUROLOGICAL DISEASE. THEREFORE, THERE HAS BEEN NO PM PERFORMED. THE SURGEON IS HAPPY FOR ME TO CONCLUDE THIS INVESTIGATION AS THIS IS ALL THE INFORMATION THAT CAN BE COLLECTED. HE WOULD LIKE TO SEE A REPORT OF THE INVESTIGATION OF THE DEVICE HOWEVER, WHEN THIS IS MADE AVAILABLE. I HAVE DISCUSSED THE STEPS I HAVE PUT INTO PLACE WITH THE LEAD CT SISTER, IN TERMS OF TRAINING WITH THE SCRUB STAFF TO HELP ELIMINATE GAPS IN KNOWLEDGE AND SKILL RELATING TO HANDLING ETHICON STAPLING DEVICES."

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. ADDITIONAL INFORMATION: LOT# J4AE98 BELONGS TO AN EC45A AND EVENT DESCRIPTION READS THE SAME, PLEASE CONFIRM THAT A EC45A WAS USED. YES I CAN CONFIRM A EC45A WAS USED IN THE PROCEDURE. WAS THE CARTRIDGE CORRECT INSERTED, DID THEY HEAR THE ¿CLICK¿? THEY DO NOT THINK THEY HEARD A CLICK, A BRAND NEW SCRUB NURSE WHO HAD NOT USED THE DEVICE BEFORE LOADED THE STAPLER AND THEREFORE WAS NOT EXPERIENCED WITH THE DEVICE. WAS IT USED ON THICK TISSUE? YES THE DEVICE WAS USED ON LUNG TISSUE. DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. WAS THE DEVICE FULLY ARTICULATED? DEGREE OF ARTICULATION? IT WAS NOT ARTICULATED AT ALL, IT WAS IN THE STRAIGHT POSITION. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NO OTHER CARTRIDGE USED. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO BUTTRESSING MATERIAL WAS NOT USED. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO IT WAS NOT. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? A CRUNCHING NOISE WAS HEARD WHEN FIRING THE DEVICE. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO HAS ADDITIONAL TISSUE TO BE CUT OUT? IF YES, PLEASE SPECIFY THE AMOUNT OF ADDITIONAL TISSUE IN CM? TISSUE HAD TO BE CUT AROUND THE DEVICE TO RELEASE IT FROM THE LUNG TISSUE, I HAVE REQUESTED ADDITIONAL INFORMATION FROM THE SURGEON AND WILL UPDATE YOU ONCE I HAVE RECEIVED A RESPONSE. HAS THIS ANY IMPACT ON THE PATIENT, THE SURGERY OR THE HEALING PROCESS? THE PATIENT HAD TO BE CONVERTED FROM A MINIMALLY INVASIVE PROCEDURE TO AN OPEN PROCEDURE DUE TO ISSUES WITH RELEASING THE JAWS FROM THE TISSUE. THIS WOULD HAVE A CONSIDERABLE IMPACT ON THE PATIENTS RECOVERY. AS PER THE COMPLAINT, THERE WAS INCREASE BLOOD LOSS (500ML DURING THE PROCEDURE AND ADDITIONAL 150ML THROUGH A DRAIN) AND THE PATIENT HAD TO SPEND TIME IN THE ICU UNIT. SINCE THERE WAS BLEEDING, IS IT POSSIBLE THAT THE PATIENT¿S HEALTH HISTORY OR ANATOMY CONTRIBUTED TO THE DIFFICULTIES THAT WERE ENCOUNTERED? THIS INFORMATION IS NOT AVAILABLE, I HAVE REQUESTED ADDITIONAL INFORMATION FROM THE SURGEON. WAS A TRANSFUSION REQUIRED? I HAVE REQUESTED ADDITIONAL INFORMATION FROM THE SURGEON. WAS THE PATIENT TAKING ANY ANTICOAGULANTS? IF YES, SPECIFY PRESCRIBED MEDICATION. THIS INFORMATION IS NOT AVAILABLE, I HAVE REQUESTED ADDITIONAL INFORMATION THROUGH THE SURGEON. DOES PATIENT HAVE A KNOWN COAGULATION DISORDER? THIS INFORMATION IS NOT AVAILABLE. HAS THE PATIENT TAKEN ANY STEROIDS? NOT AVAILABLE. WHAT WAS THE PATIENT¿S PRE-OP HEMOGLOBIN AND HEMATOCRIT? NOT AVAILABLE WHAT WAS THE PATIENT¿S POST OPERATIVE HEMOGLOBIN AND HEMATOCRIT? NOT AVAILABLE. HOSPITALIZATION EXTENDED? HOW MUCH ADDITIONAL TIME? NOT AVAILABLE. WHAT IS THE AGE AND SEX OF THE PATIENT? NOT AVAILABLE, INFORMATION REQUESTED. WHAT IS THE CURRENT STATUS OF THE PATIENT? NOT AVAILABLE, INFORMATION REQUESTED. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? I HAVE REQUESTED ADDITIONAL INFORMATION FROM THE SURGEON AND I AM WAITING FOR A RESPONSE. ADDITIONAL INFORMATION: LOT# J4AE98 BELONGS TO AN EC45A AND EVENT DESCRIPTION READS THE SAME, PLEASE CONFIRM THAT A EC45A WAS USED. YES I CAN CONFIRM A EC45A WAS USED IN THE PROCEDURE. WAS THE CARTRIDGE CORRECT INSERTED, DID THEY HEAR THE ¿CLICK¿? THEY DO NOT THINK THEY HEARD A CLICK, A BRAND NEW SCRUB NURSE WHO HAD NOT USED THE DEVICE BEFORE LOADED THE STAPLER AND THEREFORE WAS NOT EXPERIENCED WITH THE DEVICE. WAS IT USED ON THICK TISSUE? YES THE DEVICE WAS USED ON LUNG TISSUE. DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. WAS THE DEVICE FULLY ARTICULATED? DEGREE OF ARTICULATION? IT WAS NOT ARTICULATED AT ALL, IT WAS IN THE STRAIGHT POSITION. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NO OTHER CARTRIDGE USED. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO BUTTRESSING MATERIAL WAS NOT USED. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO IT WAS NOT. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? A CRUNCHING NOISE WAS HEARD WHEN FIRING THE DEVICE. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO HAS ADDITIONAL TISSUE TO BE CUT OUT? IF YES, PLEASE SPECIFY THE AMOUNT OF ADDITIONAL TISSUE IN CM? TISSUE HAD TO BE CUT AROUND THE DEVICE TO RELEASE IT FROM THE LUNG TISSUE, I HAVE REQUESTED ADDITIONAL INFORMATION FROM THE SURGEON AND WILL UPDATE YOU ONCE I HAVE RECEIVED A RESPONSE. HAS THIS ANY IMPACT ON THE PATIENT, THE SURGERY OR THE HEALING PROCESS? THE PATIENT HAD TO BE CONVERTED FROM A MINIMALLY INVASIVE PROCEDURE TO AN OPEN PROCEDURE DUE TO ISSUES WITH RELEASING THE JAWS FROM THE TISSUE. THIS WOULD HAVE A CONSIDERABLE IMPACT ON THE PATIENTS RECOVERY. AS PER THE COMPLAINT, THERE WAS INCREASE BLOOD LOSS (500ML DURING THE PROCEDURE AND ADDITIONAL 150ML THROUGH A DRAIN) AND THE PATIENT HAD TO SPEND TIME IN THE ICU UNIT. SINCE THERE WAS BLEEDING, IS IT POSSIBLE THAT THE PATIENT¿S HEALTH HISTORY OR ANATOMY CONTRIBUTED TO THE DIFFICULTIES THAT WERE ENCOUNTERED? THIS INFORMATION IS NOT AVAILABLE, I HAVE REQUESTED ADDITIONAL INFORMATION FROM THE SURGEON. WAS A TRANSFUSION REQUIRED? I HAVE REQUESTED ADDITIONAL INFORMATION FROM THE SURGEON. WAS THE PATIENT TAKING ANY ANTICOAGULANTS? IF YES, SPECIFY PRESCRIBED MEDICATION. THIS INFORMATION IS NOT AVAILABLE, I HAVE REQUESTED ADDITIONAL INFORMATION THROUGH THE SURGEON. DOES PATIENT HAVE A KNOWN COAGULATION DISORDER? THIS INFORMATION IS NOT AVAILABLE. HAS THE PATIENT TAKEN ANY STEROIDS? NOT AVAILABLE. WHAT WAS THE PATIENT¿S PRE-OP HEMOGLOBIN AND HEMATOCRIT? NOT AVAILABLE. WHAT WAS THE PATIENT¿S POST OPERATIVE HEMOGLOBIN AND HEMATOCRIT? NOT AVAILABLE. HOSPITALIZATION EXTENDED? HOW MUCH ADDITIONAL TIME? NOT AVAILABLE. WHAT IS THE AGE AND SEX OF THE PATIENT? NOT AVAILABLE, INFORMATION REQUESTED. WHAT IS THE CURRENT STATUS OF THE PATIENT? NOT AVAILABLE, INFORMATION REQUESTED. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? I HAVE REQUESTED ADDITIONAL INFORMATION FROM THE SURGEON AND I AM WAITING FOR A RESPONSE. THE ANALYSIS FOUND THAT ONE EC45A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ECR45B CARTRIDGE RELOAD PRESENT. THE CARTRIDGE WAS RECEIVED UNFIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH THE RETURNED CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED DURING THE FUNCTIONAL TEST. THE CARTRIDGE WAS LOADED INTO THE DEVICE WITHOUT DIFFICULTIES AND DID NOT FALL OUT DURING THE VISUAL AND FUNCTIONAL TESTING. THE KNIFE REVERSE BUTTON WORKED AS INTENDED. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VATS WEDGE RESECTION PROCEDURE THE STAPLER WAS UNPACKED AND LOADED WITH A GREEN CARTRIDGE BY THE SCRUB NURSE. IT WAS PASSED TO THE SURGEON AND HE CLOSED THE DEVICE ON THE LUNG. HE USED THE STAPLER TO RETRACT THE LUNG AND AS HE DID THE CARTRIDGE FELL OUT OF THE STAPLER AND THIS PROCESS ENDED IN DAMAGE TO THE LUNG. THE DEVICE REMAINED FIXED ON THE LUNG WITHOUT THE CARTRIDGE IN PLACE. WHEN THE SURGEON TRIED TO OPEN THE JAWS USING THE CONTROL RELEASE BUTTON THE JAWS WOULD NOT OPEN. THE SURGEON TRIED TO USE THE RED REVERSE BUTTON AND SQUEEZE THE FIRING TRIGGER; HOWEVER, THE JAWS WOULD STILL NOT OPEN. THE SURGEON HAD TO CONVERT THE PROCEDURE TO OPEN AND CUT THE STAPLER FROM THE TISSUE RESULTING IN 500ML BLOOD LOSS, EXTENDED THEATRE TIME AND ADVERSE PATIENT OUTCOME. THERE WAS DAMAGE TO THE LUNG AS THE SURGEON STRUGGLED TO REMOVE THE DEVICE FROM THE TISSUE. THE PATIENT HAD TO HAVE A FULL THORACOTOMY AND LOST 500ML OF BLOOD PLUS AN ADDITIONAL 150ML THROUGH A DRAIN OVER A 12 HOUR PERIOD. HOSPITALIZATION WAS REQUIRED. PATIENT WAS STABLE IMMEDIATELY AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254741 ECHELON 45 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4AE98

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention