BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 15679967 · Received October 27, 2022

    Report

    Report Number
    3005075853-2022-07288
    Event Type
    Death
    Date Received
    October 27, 2022
    Date of Event
    March 12, 2022
    Report Date
    October 27, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF EVENT: PUBLICATION DATE, EXACT EVENT DATE UNK. BATCH # UNK. 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, HARMONIC SHEAR AND ECHELON STAPLER CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS OR DEATH MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. 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: THE ASSOCIATION OF HELICOBACTER PYLORI, ERADICATION, AND EARLY COMPLICATIONS OF LAPAROSCOPIC SLEEVE GASTRECTOMY. AUTHOR: ADAM ABU ABEID, SUBHI ABU ABEID, ERAN NIZRI, JOSEPH KURIANSKY, GUY LAHAT, DANIT DAYAN. CITATION: OBESITY SURGERY (2022) 32:1617¿1623 HTTPS://DOI.ORG/10.1007/S11695-022-05996-Z. THE AIM OF THIS STUDY IS TO EXAMINE THE PREVALENCE OF HP IN ALL CONSECUTIVE SG SPECIMENS, THE ASSOCIATION TO EARLY POSTOPERATIVE COMPLICATIONS, AND THE IMPACT OF PREOPERATIVE HP ERADICATION ON OUTCOMES. THIS IS A RETROSPECTIVE ANALYSIS OF ALL CONSECUTIVE PATIENTS WHO UNDERWENT SG BETWEEN JANUARY 2012 AND DECEMBER 2020 IN A SINGLE BARIATRIC CENTER. DATA WERE RETRIEVED FROM OUR PROSPECTIVELY MAINTAINED PATIENT REGISTRY DATABASE. THE 30-DAY OUTCOMES WERE COMPARED ACCORDING TO THE HP STATUS OF THE RESECTED SPECIMEN: POSITIVE AND NEGATIVE, WITH OR WITHOUT PREOPERATIVE HP ERADICATION THERAPY. HARMONIC SCALPEL (ETHICON ENDO-SURGERY, INC.) AND ENDO-STAPLER OF ECHELON (ETHICON ENDO-SURGERY, INC.) WAS USED. REPORTED COMPLICATIONS INCLUDED STAPLE LINE LEAK (N=26), BLEEDING (N=56), OBSTRUCTION (N=3), INTRA-ABDOMINAL FLUID COLLECTION (N=41), RESPIRATORY COMPLICATIONS (N=6), VENOUS THROMBOEMBOLISM (N=2), HEMATOMA (N=36), CLAVIEN DINDO GRADE III (N=64), MORTALITY DUE TO STAPLE LINE LEAK WITH SEVERE SEPSIS (N=3). IN CONCLUSION THE PRESENCE OF HP DOES NOT SEEM TO AFFECT THE EARLY OUTCOMES OF SG. ERADICATION OF HP DOES NOT CHANGE THE EARLY POSTOPERATIVE COURSE EITHER. THEREFORE, OUR FINDINGS SUGGEST THAT THE ROLE OF ROUTINE PREOPERATIVE HP SCREENING AND ERADICATION MAY BE LIMITED IN SG PATIENTS. ERADICATION CAN BE COMPLETED FOLLOWING SG ACCORDING TO THE HPSTATUS OF THE SPECIMEN. THE POSSIBLE ASSOCIATION BETWEEN HP AND SYSTEMIC RATHER THAN GASTRIC-RELATED COMPLICATION NEEDS FURTHER INVESTIGATION, AS IT MAY WARRANT PREOPERATIVE ERADICATION, ESPECIALLY IN POPULATIONS WITH HIGH ENDEMIC INCIDENCE OF HP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2557035 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death