BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GST GOLD RELOAD 60MM 6 ROW

    MDR report key: 22544242 · Received July 18, 2025

    Report

    Report Number
    3005075853-2025-05694
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    January 1, 2023
    Report Date
    July 18, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014690
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/18/2025 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. ATTEMPT MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS 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

    TITLE: ANATOMIC SEGMENTECTOMY AND LOBECTOMY FOR NON-SMALL CELL LUNG CANCER WITH GROUNDGLASS NODULES AUTHOR'S: WANG QIANG, YU WUXIN, ZHU XIAOBO, ZHANG JUNJIE CITATION: ] R734.2 2096-2665.2023.13.0011.04 DOI: 10.3969/J.ISSN .2096-2665.2023.13.004. THE AIM OF THIS STUDY IS TO STUDY THE EFFECT OF ANATOMICAL SEGMENTECTOMY OR LOBECTOMY IN THE TREATMENT OF GROUND-GLASS NODULE (GGO) NON-SMALL CELL LUNG CANCER (NSCLC). METHOD SELECTION FROM (B)(6) 2022, 94 PATIENTS WITH GGO TYPE NON-SMALL CELL LUNG CANCER ADMITTED TO (B)(6) HOSPITAL WERE STUDIED AND DIVIDED INTO OBSERVATION GROUPS BY RANDOM NUMBER TABLE. THE PATIENTS IN THE OBSERVATION GROUP WERE TREATED WITH ANATOMICAL SEGMENTECTOMY, AND THE PATIENTS IN THE CONTROL GROUP WERE TREATED WITH ANATOMICAL LOBECTOMY. STAPLER (JOHNSON AND JOHNSON; EES) WAS USED TO TRANSECT THE PULMONARY ARTERY, VEIN, BRONCHUS AND HYPOPLASTIC INTERLOBAR FISSURE, AND THE LOBE WHERE THE LESION WAS LOCATED WAS RESECTED. REPORTED COMPLICATIONS: STAPLER (JOHNSON AND JOHNSON; EES) OBSERVATION GROUP (N=47) ATRIAL FIBRILLATION (N=1) TREATMENT: NOT REPORTED LUNG INFECTION (N=2) TREATMENT: NOT REPORTED AIR LEAKAGE (N=2) TREATMENT: NOT REPORTED. IN CONCLUSION, ANATOMICAL SEGMENTECTOMY FOR GGO NONSMALL CELL LUNG CANCER HAD LITTLE EFFECT ON PULMONARY FUNCTION, WHICH WAS BENEFICIAL TO REDUCE POSTOPERATIVE DRAINAGE VOLUME AND PROMOTE POSTOPERATIVE REHABILITATION, WITH GOOD SAFETY. IT HAS GOOD APPLICATION VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401299 GST GOLD RELOAD 60MM 6 ROW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036014690

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention