BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 45 (EXACT CODE UNKNOWN)

    MDR report key: 22375429 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05023
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    July 17, 2023
    Report Date
    July 1, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. 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 BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. 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: COMPARISON OF PATIENT-REPORTED OUTCOMES AND CLINICAL OUTCOMES BETWEEN PLEURECTOMY AND PLEURAL COVERING ADDED TO THORACOSCOPIC BULLECTOMY FOR PRIMARY SPONTANEOUS PNEUMOTHORAX. AUTHORS: KEISUKE KOBAYASHI1, HIDEO ICHIMURA1,2, SHUNTARO KAWABATA1, HISASHI SUZUKI1, KATSUYUKI ENDO1, NAOHIRO KOBAYASHI2, SHINJI KIKUCHI2, YUKINOBU GOTO2, YUKIO SATO2 CITATION: J THORAC DIS 2023;15(7):3818-3828. HTTPS://DX.DOI.ORG/10.21037/JTD-23-214. THE STUDY AIMED TO COMPARE PATIENT-REPORTED OUTCOMES (PROS) AND CLINICAL OUTCOMES BETWEEN PARIETAL PLEURECTOMY (PLEURECTOMY) AND VISCERAL PLEURAL COVERING WITH ABSORBABLE PROSTHESIS (COVERING) ADDED TO THORACOSCOPIC BULLECTOMY IN PATIENTS WITH PSP. FROM JANUARY 2015 TO APRIL 2018, A TOTAL OF 55 PATIENTS UNDERWENT SURGERY FOR PRIMARY SPONTANEOUS PNEUMOTHORAX (PSP) WERE INCLUDED IN THE STUDY. AMONG THESE, 26 PATIENTS (20 MALE AND 6 FEMALE; MEAN AGE OF 26.5 [14¿49] YEARS) UNDERWENT COVERING WHILE 29 PATIENTS (25 MALE AND 4 FEMALE; MEAN AGE OF 26.4 [15¿49] YEARS) UNDERWENT PLEURECTOMY. PULMONARY LESIONS (APICAL PLEURAL THICKENING, BLEBS, AND BULLAE), WITH OR WITHOUT AIR LEAKAGE, WERE RESECTED WITH ENDOSCOPIC AUTO-SUTURE DEVICES (ENDO GIA ULTRA UNIVERSAL STAPLER, COVIDIEN, NORWALK, CT, USA OR ECHELON 45 FLEX, ETHICON ENDO-SURGERY, CINCINNATI, OH, USA). IN THE PLEURECTOMY PROCEDURE, PARIETAL PLEURECTOMY WAS PERFORMED BY BLUNT DISSECTION. THE CAUDAL BORDER OF THE PLEURECTOMY WAS AT THE LEVEL OF THE FIFTH RIB VENTRALLY AND THE SIXTH RIB DORSALLY. THE CRANIAL BORDER WAS AT THE LEVEL OF THE FIRST RIB, AND THE PLEURA OF THE THORACIC APEX AND MEDIASTINUM WERE SPARED TO PREVENT NERVE AND VESSEL DAMAGE. IN THE COVERING PROCEDURE, THE EDGES OF THE STAPLE LINE WERE LIGATED WITH A PRE-TIED ABSORBABLE MONOFILAMENT LOOP LIGATURE (ENDOLOOP LIGATURE, ETHICON ENDO-SURGERY), AND THE APEX OF THE UPPER LOBE OF THE LUNG WAS COVERED WITH A POLYGLYCOLIC ACID (PGA) SHEET (NEOVEIL, 10 CM × 10 CM; GUNZE LTD., KYOTO, JAPAN). POSTOPERATIVE MEDIAN FOLLOW-UP TIME WAS 38 MONTHS FOR ALL CASES, 35 MONTHS IN THE COVERING GROUP, AND 42 MONTHS IN THE PLEURECTOMY GROUP. REPORTED COMPLICATIONS INCLUDE PULMONARY FISTULA OR PERIOPERATIVE RECURRENCE, PLEURAL EFFUSION, LATE RECURRENCE, PERSISTENT SYMPTOM COMPLAINED OF PAIN AND DISCOMFORT OF THE CHEST, AND DYSPNEA. IN CONCLUSION, PATIENT-REPORTED OUTCOMES (PROS) AND CLINICAL OUTCOMES WERE COMPARABLE BETWEEN THE TWO PROCEDURES. FURTHER STUDIES ARE REQUIRED TO DETERMINE THE OPTIMAL TREATMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381221 ECHELON 45 (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention