BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT

    MDR report key: 21468117 · Received February 26, 2025

    Report

    Report Number
    3005075853-2025-01515
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    January 20, 2024
    Report Date
    February 26, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 2/26/2025. D4: BATCH # UNK. 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 DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: CLINICAL MANAGEMENT OF MAJOR POSTOPERATIVE BLEEDING AFTER BARIATRIC SURGERY. AUTHORS: LARS KOLLMANN, MAXIMILIAN GRUBER, JOHAN F. LOCK, CHRISTOPH-THOMAS GERMER, FLORIAN SEYFRIED. CITATION: OBESITY SURGERY (2024) 34:751-759. HTTPS:/ /DOI.ORG/ 10.1007 /S 11695-023-07040-0. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO ANALYZE THE CLINICAL PRESENTATION AND OUTCOMES OF MPOB (MAJOR POSTOPERATIVE BLEEDING) AFTER BARIATRIC SURGERY AND TO IDENTIFY RISK FACTORS FOR MPOB. SECONDLY, WE INTENDED TO PROPOSE A PATHWAY FOR COMPREHENSIVE DECISION-MAKING AND CLINICAL MANAGEMENT OF MPOB DEPENDING ON ITS CLINICAL PRESENTATION AND THE TYPE OF SURGERY. BETWEEN 2012 TO 2022, 1017 PATIENTS, OF WHOM 667 UNDERWENT GASTRIC BYPASS (GB) AND 350 SLEEVE GASTRECTOMY (SG). ALL SLEEVE GASTRECTOMIES WERE STAPLED USING ENDOGIA® ULTRA 60-MM PURPLE LINEAR MAGAZINES (COVIDIEN, DUBLIN, IRELAND). IN ALL ROUX-EN-Y GASTRIC BYPASS PROCEDURES THE JEJUNO-JEJUNOSTOMY WAS PERFORMED USING ECHELON FLEX® LINEAR STAPLERS 60-MM WHITE MAGAZINES (ETHICON, HAMBURG, GERMANY). THE POUCH-GASTRO-JEJUNOSTOMY WAS PERFORMED USING A 25-MM CIRCULAR STAPLER (ETHICON, HAMBURG, GERMANY) WITH INSERTION OF THE ANVIL VIA THE REMNANT STOMACH. THE GASTRIC TRANSSECTION WAS PERFORMED USING ECHELON FLEX® LINEAR STAPLERS 60-MM BLUE MAGAZINES (ETHICON, HAMBURG, GERMANY). THE MESENTERIC GAPS WERE CLOSED BY 5-MM STAPLER DEVICES UNTIL 2020, THEREAFTER A RUNNING NON-RESORBABLE POLYFILE 2-0 SUTURE WAS USED. PATIENTS UNDERWENT POSTOPERATIVE FOLLOW-UP IN THE OUTPATIENT CLINIC 6 WEEKS AFTER DISCHARGE WITH A RATE > 98%. REPORTED COMPLICATIONS INCLUDED: ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT (ETHICON). ECHELON FLEX® LINEAR STAPLERS (60-MM WHITE MAGAZINES; ETHICON). ECHELON FLEX® LINEAR STAPLERS (60-MM BLUE MAGAZINES; ETHICON). 25-MM CIRCULAR STAPLER (ETHICON). - CLAVIEN-DINDO GRADE>II FOR MAJOR POSTOPERATIVE BLEEDING. (N=?) TREATMENT: BLOOD TRANSFUSIONS, ENDOSCOPIC INTERVENTIONS, REOPERATIONS. IN CONCLUSION, POSTOPERATIVE BLEEDING IS THE MOST FREQUENT SEVERE POSTOPERATIVE COMPLICATION AFTER BARIATRIC SURGERY. MAJOR POSTOPERATIVE BLEEDING OCCURS MORE OFTEN AFTER GB THAN AFTER SG. THE BLEEDING SITE AFTER GASTRIC BYPASS IS ENDOLUMINAL IN MORE THAN 60% AND THEREFORE CLINICALLY MORE OBVIOUS. MAJOR POSTOPERATIVE BLEEDING AFTER SG IS MORE SEVERE AND AT THE ABDOMINAL SITE. OUR DATA SUGGEST THAT PATIENTS WITH MAJOR POB AFTER SG SHOULD BE ADMINISTERED TO REVISIONAL SURGERY WHILE AN ENDOSCOPY FIRST APPROACH SHOULD BE FAVORED FOR PATIENTS AFTER GB. THESE FINDINGS NEED TO BE CONFIRMED BY MULTICENTER OR NATIONAL REGISTRY-BASED STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039186 ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention