BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 19807591 · Received July 23, 2024

    Report

    Report Number
    3005075853-2024-05322
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    June 18, 2021
    Report Date
    July 23, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/23/2024. 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: AS THE SERIAL 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. D4: UDI: THE MANUFACTURING 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 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: A PROSPECTIVE COMPARATIVE STUDY OF THORACOSCOPIC TRANSAREOLAR AND UNIPORTAL APPROACHES FOR YOUNG MALE PATIENTS WITH PRIMARY SPONTANEOUS PNEUMOTHORAX AUTHOR'S: HITOSHI IGAI1 · MITSUHIRO KAMIYOSHIHARA1 · SHINYA FURUSAWA1 · FUMI OHSAWA1 · TOMOHIRO YAZAWA1 ·NATSUMI MATSUURA1 CITATION: HTTPS://DOI.ORG/10.1007/S11748-021-01647-9. IN THIS STUDY, WE INTRODUCE A NOVEL APPROACH, THORACOSCOPIC TRANSAREOLAR BULLECTOMY, FOR TREATING YOUNG MALE PATIENTS WITH PRIMARY SPONTANEOUS PNEUMOTHORAX (PSP). THIS APPROACH MIGHT BE LESS INVASIVE AND COSMETICALLY SUPERIOR TO EXISTING METHODS. WE ALSO PROSPECTIVELY COMPARED TRANSAREOLAR AND UNIPORTAL APPROACHES. BETWEEN APRIL 2018 AND JULY 2019, 40 PATIENTS WERE PROSPECTIVELY ASSIGNED TO TRANSAREOLAR (N=21) AND UNIPORTAL (N=19) GROUPS. AFTER CONFIRMATION OF THE PRESENCE OF BLEBS OR BULLAE, WE EXCISED THEM USING AN ENDOSTAPLER (POWERED ECHELON FLEX GST SYSTEM; JOHNSON & JOHNSON). WE THEN APPLIED POLYGLYCOLIC ACID FELT (NEOVEIL, SHEET TYPE; IGAKI MEDICAL PLANNING CO., LTD., KYOTO, JAPAN) TO THE STAPLE LINES USING FIBRIN GLUE (BERIPLAST P; CSL BEHRING, KING OF PRUSSIA, PA, USA); THIS PREVENTED ANY POSTOPERATIVE AIR LEAKAGE AND REDUCED THE RECURRENCE RATE. IN CONCLUSION, ALTHOUGH THE PERIOPERATIVE RESULTS OF THE TRANSAREOLAR AND UNIPORTAL APPROACHES WERE SIMILAR, THE FORMER APPROACH AFFORDED A LITTLE BETTER COSMETIC SATISFACTION AND MIGHT BE USEFUL OPTION FOR YOUNG MALES WITH PSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005397 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention