BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*PROBE PLUS II SHAFT

    MDR report key: 22361041 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04831
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    August 18, 2023
    Report Date
    June 30, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K912492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/30/2025. B3: PUBLICATION YEAR OF 2023. 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 BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA: 014204. 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. 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

    TITLE: URETER INJURY IN TOTAL LAPAROSCOPIC HYSTERECTOMY AUTHOR: HIROHARU KOBAYASHI, AIMI ODA, YOSHIHIKO MATSUZAKI, YUKI KONDO, YURI HAMADA, MASARU NAGASHIMA, MISA KOBAYASHI, YOSHIHIRO TAKAKI, AND HIROSHI ADACHI CITATION: CASE REPORTS IN OBSTETRICS AND GYNECOLOGY/VOLUME 2023, ARTICLE ID 5071080, 10 PAGES/HTTPS://DOI.ORG/10.1155/2023/5071080. THE AIM OF THE STUDY WAS TO IDENTIFY SURGICAL MANIPULATIONS THAT CAUSED URETER INJURY DURING TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) AND EVALUATE THE SURGICAL MANIPULATIONS TO IDENTIFY WAYS TO PREVENT SUCH INJURY. SINGLE-CENTER, CROSS-SECTIONAL STUDY INCLUDED 1135 CASES OF TLH PERFORMED FOR BENIGN DISEASES FROM JANUARY 2009 TO DECEMBER 2021. SEVEN CASES THAT NEEDED URETERAL STENT PLACEMENT INTRA- OR POSTOPERATIVELY FOR URETER INJURY. REPORTED COMPLICATIONS ARE ABSCESS, INFECTION, ADHESION, URETER INJURY AND BLEEDING. IN CONCLUSION, TO PREVENT URETER INJURY DURING TLH, THE URETER SHOULD BE ISOLATED IN CASE OF SEVERE ADHESION. MOREOVER, THE FOLLOWING COULD BE CONSIDERED: (1) EXPAND OKABAYASHI¿S PARARECTAL SPACE LATERAL TO THE UTEROSACRAL LIGAMENT, (2) PERFORM DISSECTION SHARPLY USING A MONOPOLAR OR SCISSORS FORCEPS WHEN RELEASING ADHESION, (3) CLARIFY THE ANATOMY AROUND THE URETER FOR CASES NEEDING HEMOSTASIS, (4) REPEATEDLY CONFIRM THE URETER WITH ITS PERISTALSIS EVEN AFTER ITS ISOLATION, (5) FOR SEVERE ADHESION CASES, REDUCE INFECTION RISK BY DRAIN PLACEMENT AND ADMINISTERING ANTIBIOTICS, AND (6) USE A DELINEATOR CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929142 ENDOPATH*PROBE PLUS II SHAFT LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR.