BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN)

    MDR report key: 22237645 · Received June 17, 2025

    Report

    Report Number
    3005075853-2025-04568
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    January 1, 2013
    Report Date
    June 17, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/17/2025. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: OKABE H, OBAMA K, TANAKA E, TSUNODA S, AKAGAMI M, SAKAI Y. LAPAROSCOPIC PROXIMAL GASTRECTOMY WITH A HAND-SEWN ESOPHAGO-GASTRIC ANASTOMOSIS USING A KNIFELESS ENDOSCOPIC LINEAR STAPLER. GASTRIC CANCER. 2013 APR;16(2):268-74. DOI: 10.1007/S10120-012-0181-2. EPUB 2012 JUL 24. PMID: 22825361. THIS STUDY AIMS TO REPORT A NOVEL LAPAROSCOPIC PROCEDURE USING A KNIFELESS ENDOSCOPIC LINEAR STAPLER FOR THE EASIER CREATION OF A HAND-SEWN ANTERIOR ESOPHAGO-GASTRIC ANASTOMOSIS, WHICH RESULTED IN EXCELLENT POSTOPERATIVE FUNCTION. BETWEEN AUGUST 2009 AND DECEMBER 2011, A TOTAL OF 10 PATIENTS (6 MALES AND 4 FEMALES) UNDERWENT LAPAROSCOPIC PROXIMAL GASTRECTOMY WHILE USING ENDOPATH ETS 45 MM NO KNIFE (ETHICON ENDO-SURGERY) AND 3-0 VICRYL (ETH). REPORTED COMPLICATIONS ARE ENDOPATH ETS 45 MM NO KNIFE (ETHICON ENDO-SURGERY) 3-0 VICRYL (ETH). N=1 ANASTOMOTIC STENOSIS. TREATMENT: SERIAL ENDOSCOPIC DILATATION OF THE ANASTOMOTIC SITE. IN CONCLUSION, THE SHORT-TERM OUTCOME OF THIS NOVEL TECHNIQUE OF LAPAROSCOPIC ESOPHAGO-GASTROSTOMY WAS EXCELLENT. FIXATION OF THE ESOPHAGUS TO THE ANTERIOR STOMACH WALL WITH A KNIFELESS LINEAR STAPLER CONTRIBUTES TO AN EASIER HAND-SEWN ANASTOMOSIS AND TO COMPLETION OF THE FUNDOPLICATION. WE BELIEVE OUR METHOD IS A FEASIBLE CHOICE FOR SELECTED PATIENTS. HOWEVER, CAREFUL AND LONGER FOLLOW UP OF MORE PATIENTS IS NECESSARY TO DETERMINE THE ADVANTAGES OF OUR METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447843 ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention