BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 22411694 · Received July 7, 2025

    Report

    Report Number
    3005075853-2025-05176
    Event Type
    Injury
    Date Received
    July 7, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 07/07/2025 B3: DATE OF EVENT UNKNOWN. D4: BATCH #UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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. H4: THE DEVICE MANUFACTURE DATE IS CURRENTLY NOT AVAILABLE. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED. 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. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. 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: COMPUTED TOMOGRAPHY-GUIDED PERCUTANEOUS HOOK WIRE LOCALIZATION OF PULMONARY NODULAR LESIONS BEFORE VIDEO-ASSISTED THORACOSCOPIC SURGERY: HIGHLIGHTING TECHNICAL ASPECTS. AUTHORS: JAE BUM PARK, SONG AM LEE, WOO SURNG LEE, YO HAN KIM, INYOUNG SONG, JEONG GEUN LEE, JAE JOON HWANG. CITATION: ANN THORAC MED. 2019; 14: 205-12. DOI:10.4103/ATM.ATM_287_18. CONFIRMING THE HISTOLOGIC DIAGNOSIS OF SMALL PULMONARY NODULES OR GROUND-GLASS OPACITY NODULES (GGNS) OF UNKNOWN ORIGIN IS DIFFICULT. THESE NODULES ARE NOT ALWAYS APPROPRIATE FOR PERCUTANEOUS TRANSTHORACIC NEEDLE BIOPSY. THE GOAL OF THE PRESENT STUDY WAS TO EVALUATE THE VALIDITY AND EFFECTIVENESS OF COMPUTED TOMOGRAPHY-GUIDED PREOPERATIVE HOOK WIRE LOCALIZATION WITH THE TECHNIQUE FOR VIDEO-ASSISTED THORASCOPIC SURGERY (VATS). THE AUTHORS RETROSPECTIVELY INVESTIGATED 113 PATIENTS (63 MALE AND 50 FEMALE PATIENTS; AGE RANGE: 20 TO 83 YEARS OLD) WHO HAD UNDERGONE PREOPERATIVE HOOK WIRE LOCALIZATION BEFORE VATS RESECTION FOR NEWLY PRESENT OR GROWING PULMONARY NODULAR LESIONS BETWEEN MAY 2017 AND DECEMBER 2016. DURING THE SURGICAL PROCEDURE, TWO ADDITIONAL ACCESS PORTS WERE ESTABLISHED FOR GRASPING THE LUNG, SWITCHING THE PORT FOR THE THORACOSCOPE, AND INSERTION OF AN ECHELON ENDOSCOPIC LINEAR STAPLER (ETHICON). WEDGE RESECTION ENSURING A SUFFICIENT RESECTION MARGIN WAS PERFORMED AFTER IDENTIFYING THE LOCALIZED NODULE LESION WITH HOOK WIRE. REPORTED COMPLICATIONS INCLUDED PERSISTENT AIR LEAKAGE (N-10). CT-GUIDED PREOPERATIVE HOOK WIRE LOCALIZATION APPEARS TO BE A FEASIBLE, CONVENIENT, AND SECURE STRATEGY TO LOCALIZE SMALL AND DEEP LUNG NODULES FOR THORACOSCOPIC WEDGE RESECTION AND ACCURATE DIAGNOSIS. A COPY OF THIS LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153579 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other