BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 18383572 · Received December 22, 2023

    Report

    Report Number
    3005075853-2023-09804
    Event Type
    Death
    Date Received
    December 22, 2023
    Date of Event
    May 27, 2023
    Report Date
    March 27, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), DATE SENT: 3/27/2024. UPON REVIEW OF THE ADDITIONAL INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A DEATH AND IS BEING CONSIDERED AS NOT REPORTABLE PER THE JOURNAL ARTICLE "NO DEATHS WERE DIRECTLY ATTRIBUTED TO THE SURGICAL INTERVENTION RECEIVED". H1- NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/22/2023. D4: BATCH # UNK. 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

    TITLE: SEVEN YEAR RESULTS OF A RANDOMIZED TRIAL COMPARING BANDED ROUX EN Y GASTRIC BYPASS TO SLEEVE GASTRECTOMY FOR TYPE 2 DIABETES AND WEIGHT LOSS. AUTHOR(S): JACK S. PULLMAN, LINDSAY D. PLANK, SHERRY NISBET, RINKI MURPHY, MICHAEL W. C. BOOTH. CITATION: HTTPS://DOI.ORG/10.1007/S11695-023-06635-X. THIS STUDY AIMED TO COMPARE INTENSIVE MEDICAL THERAPY VS BARIATRIC SURGERY PLUS INTENSIVE MEDICAL THERAPY, WITH THE BARIATRIC SURGERY GROUP HAVING ARMS FOR BOTH LSG AND LRYGB. A PROSPECTIVE, RANDOMIZED, PARALLEL, TWO-ARM, CLINICAL TRIAL COMPARING THE OUTCOMES OF SILASTIC RING (SR)-LRYGB VERSUS LSG WAS CONDUCTED AT A SINGLE (AUCKLAND, NEW ZEALAND) CENTER. FROM (B)(6) 2014, A TOTAL OF 114 PATIENTS WERE RANDOMIZED TO UNDERGO LSG (N=58) AND SRLRYGB (N=56). IN LSG GROUP WHICH CONSISTED OF A GASTRIC RESECTION USING AN ECHELON FLEX 45 STAPLER (ETHICON) OVER A 36-FR OROGASTRIC BOUGIE, COMMENCING 2 CM PROXIMAL FROM THE PYLORUS. THE REPORTED COMPLICATION INCLUDED DEATH (N=3), WOUND INFECTION (N=1) TREATMENT: DEBRIDEMENT, HEMORRHAGE (N=1) TREATMENT: NOT MENTIONED, STENOSIS (N=1) TREATMENT: HOSPITALIZATION AND VOMITING (N=1) TREATMENT: NOT MENTIONED. IN CONCLUSION, SR-LRYGB WAS SUPERIOR TO LSG FOR DIABETES REMISSION AND WEIGHT LOSS AT 7 YEARS FOLLOWING SURGERY, WITH ACCEPTABLE COMPLICATION RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288063 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death