BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 9504944 · Received December 20, 2019

    Report

    Report Number
    3005075853-2019-24654
    Event Type
    Injury
    Date Received
    December 20, 2019
    Report Date
    December 6, 2019
    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 SENT: 12/20/2019. EVENT DATE UNK. BATCH # UNK. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE : LAPAROSCOPIC ESOPHAGOGASTROSTOMY USING A KNIFELESS LINEAR STAPLER AFTER PROXIMAL GASTRECTOMY AUTHOR : MASAKI OHI1, YUJI TOIYAMA1, TAKAHITO KITAJIMA1, TSUNEHIKO SHIGEMORI1, HIROMI YASUDA1, YOSHINAGA OKUGAWA1, HIROYUKI FUJIKAWA1, YOSHIKI OKITA2, TAKESHI YOKOE1, JUNICHIRO HIRO1, TOSHIMITSU ARAKI1, MASATO KUSUNOKI. CITATION: DOI: HTTPS://DOI.ORG/10.1007/S00595-019-01836-3. PROXIMAL GASTRECTOMY SHOULD IMPROVE THE LATE POSTOPERATIVE FUNCTION IN PATIENTS WITH GASTRIC CANCER LOCATED IN THE UPPER THIRD OF THE STOMACH OR ESOPHAGOGASTRIC JUNCTION. HOWEVER, A STANDARD METHOD OF ESOPHAGOGASTROSTOMY HAS NOT BEEN ESTABLISHED FOR IMPROVING THE POSTOPERATIVE FUNCTION. TO PREVENT REFLUX AND STENOSIS FOLLOWING PROXIMAL GASTRECTOMY, THE AUTHORS INTRODUCED A NOVEL ESOPHAGOGASTROSTOMY METHOD USING A KNIFELESS LINEAR STAPLER. STARTING IN NOVEMBER 2015, LAPAROSCOPIC PROXIMAL GASTRECTOMY WITH ESOPHAGOGASTROSTOMY USING A KNIFELESS LINEAR STAPLER WAS PERFORMED IN 12 CONSECUTIVE PATIENTS (10 MALE AND 2 FEMALE PATIENTS; AGE RANGE: 53 TO 79 YEARS OLD; BMI: 18.1 TO 38.3) WITH GASTRIC CANCER AT THE DEPARTMENT OF GASTROINTESTINAL AND PEDIATRIC SURGERY OF MIE UNIVERSITY GRADUATE SCHOOL OF MEDICINE. DURING THE SURGICAL PROCEDURE, AN ENDOPATH KNIFELESS LINEAR STAPLER (ETHICON) WAS INSERTED THROUGH THE LEFT LOWER PORT, AND USING A NASOGASTRIC TUBE AS A GUIDE, A JAW WAS INSERTED INTO EACH OF THE CREATED HOLES. A 1.5-CM-LONG INCISION FROM THE EDGE OF THE ENTRY HOLES BETWEEN THE STAPLERS WAS THEN MADE USING SCISSORS, AND THE COMMON STAB HOLE WAS CLOSED BY STRATAFIX 3-0 CONTINUOUS ABSORBABLE BARBED SUTURES (ETHICON). REPORTED COMPLICATIONS INCLUDED SURGICAL SITE INFECTION (N-1) AND STENOSIS (N-1) IN WHICH ENDOSCOPIC DILATATION WAS UNNECESSARY. IN CONCLUSION, THE LAPAROSCOPIC PROCEDURE USING AN ENDOSCOPIC KNIFELESS LINEAR STAPLER CONSISTS OF A RELATIVELY SIMPLE MECHANICAL ESOPHAGOGASTROSTOMY LEADING TO A SHORTENED OPERATIVE TIME. THE AUTHORS PROPOSED THAT THIS NOVEL OPERATION MAY BE A FEASIBLE SURGICAL PROCEDURE FOR TREATING GASTRIC CANCER LOCATED IN THE UPPER THIRD OF THE STOMACH OR ESOPHAGOGASTRIC JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296047 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention