BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 16856005 · Received May 2, 2023

    Report

    Report Number
    3005075853-2023-02999
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    October 8, 2022
    Report Date
    May 2, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/2/2023. D4: BATCH # UNK. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR. 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: THE EFFECT OF STAPLE HEIGHT AND RECTAL-WALL THICKNESS ON ANASTOMOTIC LEAKAGE AFTER LAPAROSCOPIC LOW ANTERIOR RESECTION* AUTHORS: DAISHI NAOI*, HISANAGA HORIE, AI SADATOMO, KOJI KOINUMA, GAKU OTA, KENICHI OSHIRO, MAKIKO TAHARA, KATSUSUKE MORI, HOMARE ITO, YOSHIYUKI INOUE, YUKO HOMMA, TOSHIKI MIMURA, ALAN KAWARAI LEFOR, NAOHIRO SATA. CITATION: ASIAN JOURNAL OF SURGERY (2023); 46:1577-1582. HTTPS://DOI.ORG/10.1016/J.ASJSUR.2022.09.093. THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECT OF STAPLE HEIGHT AND RECTAL WALL THICKNESS ON THE DEVELOPMENT OF AN ANASTOMOTIC LEAK AFTER LAPAROSCOPIC LOW ANTERIOR RESECTION PERFORMED WITH THE DOUBLE STAPLING TECHNIQUE. A TOTAL OF 199 PATIENTS (135 MALES AND 64 FEMALES; AGE RANGED FROM 35 TO 88 YEARS) WITH RECTAL CANCER WHO UNDERWENT LAPAROSCOPIC OR ROBOT-ASSISTED LOW ANTERIOR RESECTION (LAR) WITH A DOUBLE STAPLING TECHNIQUE (DST) ANASTOMOSIS AT (B)(6) HOSPITAL FROM (B)(6) 2013 TO (B)(6) 2021 WERE INCLUDED IN THE STUDY. ECHELON FLEX OR POWERED ECHELON FLEX GST SYSTEM [ETHICON, INC., CINCINNATI, OH, USA] WAS USED FOR RECTAL TRANSECTION. THE STAPLE HEIGHT USED IN THE LINEAR STAPLER WAS SELECTED INTRAOPERATIVELY AT THE DISCRETION OF THE SURGEON FROM AMONG 1.5 MM, 1.8 MM AND 2.0 MM STAPLES (RECOMMENDED TISSUE THICKNESS RANGE FOR STAPLE CARTRIDGES: 1.5-2.4 MM, 1.8-3 MM, AND 2-3.3 MM RESPECTIVELY. THE DIAMETER OF THE CIRCULAR STAPLER WAS SELECTED FROM AMONG 25 MM, 28 MM AND 29 MM INSTRUMENTS ACCORDING TO THE DIAMETER OF THE PROXIMAL COLON USING A SIZER INTRAOPERATIVELY. TYPE OF CIRCULAR STAPLER USED WERE PROXIMATE ILS (ETHICON, INC., CINCINNATI, OH, USA) AND EEA¿ CIRCULAR STAPLER (MEDTRONIC, CO., LTD, MINNEAPOLIS, MN, USA). REPORTED COMPLICATIONS INCLUDE ANASTOMOTIC LEAKS (N=8). IN CONCLUSION, LINEAR STAPLER STAPLE HEIGHT AND RECTAL WALL THICKNESS ARE SIGNIFICANTLY ASSOCIATED WITH THE DEVELOPMENT OF AN ANASTOMOTIC LEAK AFTER LAPAROSCOPIC LOW ANTERIOR RESECTION. LARGER STAPLES SHOULD BE SELECTED IN PATIENTS WITH A THICKER RECTAL WALL DUE TO NEOADJUVANT TREATMENT OR ADJACENT ADVANCED RECTAL TUMORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712052 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention