BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 10264459 · Received July 13, 2020

    Report

    Report Number
    3005075853-2020-03534
    Event Type
    Injury
    Date Received
    July 13, 2020
    Report Date
    June 16, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DATE OF EVENT: UNKNOWN. BATCH # UNKNOWN. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. 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. DOES THE SURGEON/AUTHOR BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: ADVANTAGES OF USING A ROBOTIC STAPLER IN RECTAL CANCER SURGERY. AUTHORS: P. TEJEDOR, F. SAGIAS, D. NOCK, K. FLASHMAN, S. NAQVI, N. LI KANDALA, JIM. S. KHAN. CITATION: JOURNAL OF ROBOTIC SURGERY (2020) 14:365¿370; DOI: HTTPS://DOI.ORG/10.1007/S11701-019-00993-4. THE AIMED OF THIS RETROSPECTIVE STUDY WAS TO COMPARE OUTCOMES BETWEEN THE PATIENTS WHO UNDERWENT A ROBOTIC TOTAL MESORECTAL EXCISION (R-TME) FOR RECTAL CANCER WITH THE USE OF THE ROBOTIC STAPLER (RS) VS. THE TRADITIONAL LAPAROSCOPIC STAPLERS (LS). BETWEEN MAY 2013 AND MAY 2018, 196 PATIENTS REQUIRED A FULL TME DOWN TO PELVIC FLOOR WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS, BASED ON THE TYPE OF STAPLER EMPLOYED TO TRANSECT THE RECTUM IN THE PELVIS: LS OR RS. FOR THE RECTAL TRANSECTION, LS GROUP ¿ LAPAROSCOPIC 45 MM STAPLER (ECHELON FLEX ENDOPATH, ETHICON) (N=145: MALE=72%, FEMALE=28%; MEAN AGE=69 YEARS, AGE RANGE=61 ¿ 76 YEARS; MEAN BMI=27 KG/M^2, BMI RANGE=24 ¿ 29 KG/M^2), WHICH WAS INTRODUCED THROUGH THE ASSISTANT TROCAR; IN RS GROUP ¿ ROBOTIC 45 MM STAPLER (N=51: MALE=67%, FEMALE=33%, MEAN AGE=72 YEARS, AGE RANGE=60 ¿ 77 YEARS; MEAN BMI=26 KG/M^2, BMI RANGE=23 ¿ 29 KG/M^2), WHICH WAS INTRODUCED THROUGH A 12 MM ROBOTIC TROCAR. REPORTED COMPLICATION INCLUDED ANASTOMOTIC LEAKAGE (AL) (N=10) WHICH HAD REOPERATION. IN CONCLUSION, MULTIPLE STAPLER FIRINGS FOR RECTAL TRANSECTION HAVE A MAJOR IMPACT ON AL. THE ROBOTIC STAPLER SIMPLIFIES THE TRANSACTION, SO THAT RECTAL DIVISION REQUIRES FEWER STAPLER FIRINGS, WITH A POTENTIAL REDUCTION IN THE INCIDENCE OF AL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726726 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention