BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 21478638 · Received February 27, 2025

    Report

    Report Number
    3005075853-2025-01543
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    October 17, 2023
    Report Date
    February 27, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 2/27/2025. 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: LONG-TERM OUTCOMES OF LAPAROSCOPIC SLEEVE GASTRECTOMY AS A REVISIONAL PROCEDURE FOLLOWING ADJUSTABLE GASTRIC BANDING: VARIATIONS IN OUTCOMES BASED ON INDICATION. AUTHORS: ANAGI WICKREMASINGHE ¿ YIT LEANG ¿ YAZMIN JOHARI ¿ PREM CHANA ¿ MEGAN ALDERUCCIO ¿ KALAI SHAW ¿ CHERYL LAURIE ¿ PETER NOTTLE ¿ WENDY BROWN ¿ PAUL BURTON. CITATION: OBESITY SURGERY (2023) 33:3722-3739. HTTPS:/ /DOI.ORG/ 10. 1007 /S 11695-023-06886-8. THE AIM OF THIS RETROSPECTIVE ANALYSIS OF PROSPECTIVELY COLLECTED DATA COLLECTED FROM 2006 TO 2021 WAS TO COMPREHENSIVELY DETERMINE THE LONG-TERM OUTCOMES OF SLEEVE GASTRECTOMY AS A REVISIONAL PROCEDURE AFTER LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB) ACROSS A RANGE OF MEASURES AND DETERMINE PREDICTORS OF OUTCOMES. A TOTAL OF 1800 PATIENTS WERE INCLUDED IN THE STUDY. THE REVISION LAPAROSCOPIC SLEEVE GASTRECTOMY (RLSG) GROUP CONSISTED OF 600 PATIENTS (87% WERE FEMALES; MEAN AGE WAS 45±19.4 YEARS), AND THE CONTROL GROUP CONSISTED OF 1200 PRIMARY LSG (PLSG) PATIENTS (78.8% WERE FEMALES; MEAN AGE WAS 44.6±16.6 YEARS). THE SLEEVE GASTRECTOMY TECHNIQUE WAS SIMILAR TO THAT PERFORMED IN PRIMARY LSG. THE TWO MAJOR TYPES OF STAPLERS USED WERE ETHICON ECHELON¿ STAPLER-ECHELON FLEX¿ STAPLER WITH GST RELOADS (ETHICON ENDO-SURGERY, INC., CINCINNATI, OH, USA) AND COVIDIEN ENDO GIA ¿/SIGNIA¿ WITH TRI-STAPLE¿ RELOADS TECHNOLOGY (COVIDIEN/MEDTRONIC, MINNEAPOLIS, MN, USA). REPORTED COMPLICATIONS INCLUDE MORTALITY/DEATH DUE TO SLEEVE LEAK (N=?), STAPLE LINE LEAKS (N=?), STENOSIS (N=?), FISTULA (N=?), THROMBOSIS (N=?), WOUND PROBLEMS (N=?), MAJOR BLEED (N=?), SEPSIS (N=?), REGURGITATION (N=?), FOOD INTOLERANCE (N=?), AND DYSPHAGIA (N=?). IN CONCLUSION, RLSG PROVIDES LONG-TERM WEIGHT LOSS, ALTHOUGH PERI-OPERATIVE COMPLICATIONS ARE SIGNIFICANTLY ELEVATED COMPARED TO PLSG. LONGER-TERM RE-OPERATION RATES ARE ELEVATED COMPARED TO PLSG. FOUR VARIABLES PREDICTED WORSE OUTCOMES: ERODED BAND, MULTIPLE PRIOR BANDS, SEVERE OESOPHAGEAL DYSMOTILITY AND ELEVATED BASELINE WEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697991 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention