BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX

    MDR report key: 24799764 · Received April 7, 2026

    Report

    Report Number
    3005075853-2026-02588
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    October 1, 2025
    Report Date
    April 7, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K141952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT: 4/7/2026. 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: FROM TRIPORTAL TO UNIPORTAL VIDEO-THORACOSCOPIC LOBECTOMY: THE SINGLE SURGEON LEARNING CURVE BY CUSUM CHART AND PERIOPERATIVE OUTCOMES AUTHORS: GIORGIA CERRETANI 1 , ELISA NARDECCHIA 2 , ELENA ASTEGGIANO 2 , ALBERTO COLOMBO 2 , DAVIDE DI NATALE 2 , LUCA FILIPPONI 2 AND NICOLA ROTOLO 1,* CITATION: CERRETANI, G.; NARDECCHIA, E.; ASTEGGIANO, E.; COLOMBO, A.; DI NATALE, D.; FILIPPONI, L.; ROTOLO, N. FROM TRIPORTAL TO UNIPORTAL VIDEOTHORACOSCOPIC LOBECTOMY: THE SINGLE SURGEON LEARNING CURVE BY CUSUM CHART AND PERIOPERATIVE OUTCOMES. SURG. TECH. DEV. 2025, 14, 34. HTTPS:// DOI.ORG/10.3390/STD14040034. THIS SINGLE-CENTER, SINGLE-SURGEON RETROSPECTIVE STUDY DOES NOT AIM TO DEFINE NEW PROFICIENCY THRESHOLDS, BUT RATHER TO CONFIRM THE APPLICABILITY OF EXISTING BENCHMARKS, SUCH AS THOSE PROPOSED BY THE ESTS, WITHIN A SINGLECENTER SETTING. OUR FINDINGS REINFORCE THAT THE ESTIMATED LEARNING CURVE FOR UNIPORTAL VATS LOBECTOMY (APPROXIMATELY 50 CASES) HOLDS EVEN IN SMALLER-VOLUME INSTITUTIONS, UNDERLINING THE CONSISTENCY OF THE LEARNING PATTERN ACROSS DIFFERENT SURGICAL ENVIRONMENTS. FROM NOVEMBER 2019 TO MAY 2023, A TOTAL OF 107 PATIENTS WHO UNDERWENT U-VATS LOBECTOMY FOR LUNG CANCER CONSECUTIVELY, INCLUDING 67 (63%) MEN AND 40 (37%) FEMALES, WITH AN AVERAGE AGE OF 69 YEARS (SD 8.94), PERFORMED BY THE SAME SURGEON, WHO SWITCHED FROM TRIPORTAL VATS TO U-VATS LOBECTOMY (CLINICAL STAGE I, II, AND IIIA); MEANWHILE, THE OTHER SURGEONS CONTINUED TO PERFORM PULMONARY LOBECTOMIES WITH THE TRIPORTAL APPROACH. ALL PROCEDURES WERE PERFORMED WITH A 10 MM, 30 DEGREE VIDEO THORACOSCOPE WITH ENDOSCOPIC INSTRUMENTS, ULTRASONIC DISSECTOR (HARMONIC SCALPEL¿ETHICON ACE®, INC., CINCINNATI, OH, USA). ENDOSCOPIC STAPLERS WERE USED TO SUTURE AND CUT THE VESSELS (ECHELON FLEX¿ POWERED VASCULAR AND STAPLER, ETHICON ACE®, INC., CINCINNATI, OH, USA) OR LIGATED BY USING HEM-O-LOCKS; IN THE SAME WAY, THE BRONCHI AND INCOMPLETE FISSURES WERE DISSECTED WITH AN ENDOSTAPLER. THE MEAN DURATION FOLLOW-UP WAS NOT REPORTED. REPORTED COMPLICATIONS: ULTRASONIC DISSECTOR HARMONIC SCALPEL (ETHICON ENDO SURGERY): ECHELON FLEX¿ POWERED VASCULAR (ETHICON ENDO SURGERY): ETHICON ACE® (ETHICON ENDO SURGERY): (N=14) PULMONARY COMPLICATIONS; TREATMENT: NOT REPORTED. (N=10) PROLONGED AIR LEAK; TREATMENT: NOT REPORTED. (N=1) PNEUMONIA; TREATMENT: NOT REPORTED. (N=3) POSTOP. PAIN, VAS SCORE VAS I GPO (1¿5); TREATMENT: NOT REPORTED. (N=2) POSTOP. PAIN, VAS SCORE VAS II GPO (1¿4); TREATMENT: NOT REPORTED. IN CONCLUSION, TO CONCLUDE, USING THE CUSUM METHODOLOGY, WE IDENTIFIED AN INFLECTION POINT AT THE 67TH CASE, AFTER WHICH OPERATIVE TIME, CONVERSION RATE, AND PERIOPERATIVE COMPLICATIONS SHOWED A SIGNIFICANT DECREASE. THESE FINDINGS SUGGEST THAT, DESPITE PRIOR EXPERIENCE WITH MULTIPORT VATS, ADOPTING THE UNIPORTAL TECHNIQUE REQUIRES A DISTINCT LEARNING PROCESS, ALIGNING WITH PREVIOUS STUDIES ON THIS TOPIC, WHICH SHOW THAT ACHIEVING PROFICIENCY IN U-VATS LOBECTOMY GENERALLY REQUIRES APPROXIMATELY 50¿70 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857827 ECHELON FLEX STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention