BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 9377511 · Received November 26, 2019

    Report

    Report Number
    3005075853-2019-23786
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    January 1, 2014
    Report Date
    July 10, 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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER IS UNKNOWN. THEREFORE, THE 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DATE OF EVENT: PUBLICATION YEAR OF 2014. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    TITLE: ONCOLOGICAL AND SURGICAL RESULTS OF LAPAROSCOPIC VERSUS OPEN LIVER RESECTION FOR HCC LESS THAN 5 CM: CASE-MATCHED ANALYSIS. AUTHOR(S): SAM-YOUL YOON, KI-HUN KIM, DONG-HWAN JUNG, AMI YU, SUNG-GYU LEE. CITATION: SURG ENDOSC (2015) 29:2628¿2634; DOI 10.1007/S00464-014-3980-1. THE AIMED OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE SURGICAL AND ONCOLOGICAL RESULTS OF LAPAROSCOPIC LIVER RESECTION (LLR) FOR HEPATOCELLULAR CARCINOMA (HCC) BY COMPARING LAPAROSCOPIC AND OPEN LIVER RESECTION (OLR). BETWEEN JULY 2007 AND AUGUST 2011, 1050 PATIENTS RECEIVED LIVER RESECTION FOR HCC. A TOTAL OF 174 PATIENTS (FEMALE=44, MALE=130; MEAN AGE 55.0 YEARS, AGE RANGE=49 ¿ 61 YEARS) WERE UNDER OLR GROUP AND 58 PATIENTS (FEMALE=13, MALE=45; MEAN AGE=54.3 YEARS, AGE RANGE=49 ¿ 63 YEARS) WERE UNDER LLR GROUP. DURING LAPAROSCOPIC LIVER RESECTION, TRANSECTION OF LIVER PARENCHYMA WAS PERFORMED USING HARMONIC SCALPEL (ETHICON). SMALL BRANCHES OF GLISSON¿S PEDICLES WERE CLIPPED BY METAL CLIP, AND LARGE GLISSON¿S PEDICLES WERE LIGATED USING A KNOT PUSHER OR ENDOSCOPIC LINEAR STAPLER (ETHICON) WITH 45 MM GOLD CARTRIDGE. AFTER PARENCHYMAL DISSECTION, ENDOSCOPIC LINEAR STAPLER (ETHICON) WITH 45 MM WHITE CARTRIDGE WAS USED TO LIGATE THE MAIN HEPATIC VEINS. REPORTED COMPLICATIONS IN LLR GROUP INCLUDED BILE LEAKAGE [HARMONIC SCALPEL (N=2); ENDOSCOPIC LINEAR STAPLER (N=?)] REQUIRING INTERVENTIONAL DRAINAGE OR STENT PLACEMENT; WOUND INFECTION [ENDOSCOPIC LINEAR STAPLER (N=3)]. IN CONCLUSION, LLR IS A SAFE AND FEASIBLE ALTERNATIVE FOR SELECTED PATIENTS WITH HCC (<5 CM) AND WAS SHOWN NOT TO INCREASE THE TUMOR RECURRENCE RISK OR ADVERSELY AFFECT ONCOLOGIC OUTCOMES. LLR IS A SAFE AND DEVELOPING TECHNIQUE IN A SELECT GROUP OF PATIENTS WITH HCC. LLR HAS THE ADVANTAGES OF RAPID RECOVERY AND LOW MORBIDITY WITH ACCEPTABLE ONCOLOGICAL AND PATHOLOGICAL PARAMETERS. IT MAY BE AN OPTIMAL AND PROMISING METHOD OF HEPATECTOMY IN HCC (<5 CM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169033 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention