BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    MDR report key: 10808573 · Received November 9, 2020

    Report

    Report Number
    3005075853-2020-05840
    Event Type
    Injury
    Date Received
    November 9, 2020
    Date of Event
    January 1, 2019
    Report Date
    October 12, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/24/2020. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS RECEIVED: SORRY, I CANNOT ANSWER TO YOUR QUESTION. IT IS SCIENTIFIC PAPER, NOT COMPANY PRODUCT REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY EVENT YEAR KNOWN: 2019; CAPTURED AS CITATION DATE. 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 AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. WHAT ARE THE SPECIFIC ¿OTHER LATE COMPLICATIONS¿ THAT WAS REPORTED IN THE CIRCULAR STAPLER GROUP (TABLE4)? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FIELD AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: INTRACORPOREAL ESOPHAGOJEJUNOSTOMY USING A CIRCULAR OR A LINEAR STAPLER IN TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY: A PROPENSITY-MATCHED ANALYSIS. AUTHORS: SO HYUN KANG, YO-SEOK CHO, SA-HONG MIN, YOUNG SUK PARK, SANG-HOON AHN, DO JOONG PARK, HYUNG-HO KIM. CITATION: J GASTRIC CANCER. 2019; 19(2): 193-201. DOI: HTTPS://DOI.ORG/10.5230/JGC.2019.19.E17. THERE IS NO CONSENSUS ON THE OPTIMAL METHOD FOR INTRACORPOREAL ESOPHAGOJEJUNOSTOMY (EJ) IN LAPAROSCOPIC TOTAL GASTRECTOMY (LTG). THIS STUDY AIMS TO COMPARE 2 ESTABLISHED METHODS OF EJ ANASTOMOSIS IN LTG. A TOTAL OF 314 PATIENTS DIAGNOSED WITH GASTRIC CANCER THAT UNDERWENT LTG IN THE PERIOD FROM JANUARY 2013 TO OCTOBER 2016 WERE ENROLLED IN THE STUDY. 254 PATIENTS UNDERWENT THE PROCEDURE WITH CIRCULAR STAPLER (174 MALE AND 80 FEMALE PATIENTS; AGE: 61.5 ± 11.9; BMI: 23.3 ± 3.1) AND 60 PATIENTS UNDERWENT WITH LINEAR STAPLER (49 MALE AND 11 FEMALE PATIENTS; AGE: 61.9 ± 12.7; BMI: 23.6 ± 2.9). FOR THE CIRCULAR STAPLER ANASTOMOSIS, REINFORCEMENT OF THE PURSE-STRING SUTURE IS PERFORMED USING AN ADDITIONAL PROLENE 2-0 SUTURE (ETHICON) OR THE ENDOLOOP (ETHICON). FOR THE CIRCULAR STAPLER ANASTOMOSIS GROUP, REPORTED COMPLICATIONS INCLUDED INTRACORPOREAL ESOPHAGOJEJUNOSTOMY (EJ) LEAKAGE (N-3), ANASTOMOSIS LEAKAGE (N-7) WHICH REQUIRED REOPERATION, BLEEDING FROM THE EJ SITE (N-1), EJ STRICTURE (N-1), INTRA-ABDOMINAL ABSCESS (N-13), STUMP LEAKAGE (N-2), LOOP OBSTRUCTION (N-1), INTERNAL HERNIA (N-10), ADHESIVE ILEUS (N-7), OTHER LATE COMPLICATIONS (N-2). PERFORMING THE EJ ANASTOMOSIS IS STILL CONSIDERED ONE OF THE MOST TECHNICALLY CHALLENGING ASPECTS OF LTG. BOTH CIRCULAR AND LINEAR STAPLING TECHNIQUES ARE FEASIBLE AND SAFE IN PERFORMING INTRACORPOREAL EJ ANASTOMOSIS DURING LTG. THE LINEAR GROUP HAD SHORTER OPERATIVE TIME, BUT THERE WAS NO DIFFERENCE IN ANASTOMOSIS COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275947 ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN) LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1