BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 10760279 · Received October 30, 2020

    Report

    Report Number
    2210968-2020-08471
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    April 9, 2019
    Report Date
    October 12, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 11/16/2020. CORRECTED INFORMATION: B1, B2, H1- UPON ADDITIONAL INFORMATION REVIEW, THIS MEDWATCH REPORT 2210968-2020-08471 DOES NOT MEET REPORTABILITY CRITERIA AND HAS BEEN UPDATED FROM SERIOUS INJURY TO NOT-REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SURGEON/AUTHOR, AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR / SURGEON BELIEVE THAT ETHICON PRODUCTS (PROLENE SUTURE AND ENDOLOOP SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? NO. WE DO NOT THINK IT WAS CAUSED BY THE PRODUCTS MENTIONED ABOVE. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE SUTURE AND ENDOLOOP SUTURE) USED IN THIS PROCEDURE? NO. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (PROLENE SUTURE AND ENDOLOOP SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE SUTURE AND ENDOLOOP SUTURE) USED IN THIS PROCEDURE? WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PLEASE PROVIDE PATIENT DEMOGRAPHICS. CITATION: J GASTRIC CANCER. 2019; 19(2): 193-201. DOI: HTTPS://DOI.ORG/10.5230/JGC.2019.19.E17.

    Description of Event or Problem · 1

    TITLE: INTRACORPOREAL ESOPHAGOJEJUNOSTOMY USING A CIRCULAR OR A LINEAR STAPLER IN TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY: A PROPENSITY-MATCHED ANALYSIS 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
    1225779 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention