BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 23276346 · Received October 15, 2025

    Report

    Report Number
    1219930-2025-04632
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    April 2, 2025
    Report Date
    October 13, 2025
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU (LOT#:UNKNOWN) TAKUYA KOHAMA. "LARGER POLYGLYCOLIC ACID SHEET PLEURAL COVERING TO REDUCE POSTOPERATIVE RECURRENCE OF PRIMARY SPONTANEOUS PNEUMOTHORAX", 2025, HTTPS://DX.DOI.ORG/10.21037/JTD-2025-24 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE, A RETROSPECTIVE SINGLE-CENTER STUDY EVALUATED 185 PATIENTS UNDER 40 YEARS OF AGE WHO UNDERWENT THORACOSCOPIC BULLECTOMY FOR PRIMARY SPONTANEOUS PNEUMOTHORAX BETWEEN MARCH 2006 AND MARCH 2020, WHERE ENDO GIA STAPLERS AND TRI-STAPLE ENDO GIA WERE USED FOR BULLAE OR BLEB RESECTION. STAPLE LINES WERE REINFORCED WITH POLYGLYCOLIC ACID (PGA) SHEETS OF DIFFERENT SIZES APPLIED USING FIBRIN GLUE, WITH 152 PATIENTS RECEIVING LARGER SHEETS (225 CM²) AND 33 PATIENTS RECEIVING SMALLER SHEETS (100 CM²). RESULTS DEMONSTRATED THAT LARGER PGA SHEETS SIGNIFICANTLY REDUCED POSTOPERATIVE RECURRENCE RATES AND WERE ASSOCIATED WITH BETTER LONG-TERM OUTCOMES. POSTOPERATIVE COMPLICATIONS INCLUDED PROLONGED AIR LEAK AND RECURRENCE OF SPONTANEOUS PNEUMOTHORAX, WITH TWO PATIENTS REQUIRING REOPERATION, WHILE THE MAJORITY OF CASES RESOLVED WITHOUT ADDITIONAL INTERVENTION. THE STUDY CONCLUDED THAT REINFORCEMENT OF ENDO GIA STAPLE LINES WITH LARGER PGA SHEETS PROVIDES SUPERIOR RECURRENCE PREVENTION AND FAVORABLE PATIENT OUTCOMES. KOHAMA T, SAKAMOTO T, TANAHASHI M, MANIWA Y. LARGER POLYGLYCOLIC ACID SHEET PLEURAL COVERING TO REDUCE POSTOPERATIVE RECURRENCE OF PRIMARY SPONTANEOUS PNEUMOTHORAX. J THORAC DIS 2025;17(7):4576-4586. DOI: 10.21037/JTD-2025-24.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2792267 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN SURGICAL UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H11