BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 25MM, CURVED

    MDR report key: 22363555 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04863
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    December 1, 2020
    Report Date
    June 30, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 6/30/2025 THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. COULD YOU PLEASE PROVIDE MORE DETAILS HOW EACH ISSUE WAS ADDRESSED FOR THE FOLLOWING EVENTS (OCCUR INTRA-OPERATIVELY OR POST-OPERATIVELY, TREATMENT, MEDICAL OR SURGICAL INTERVENTIONS PERFORMED: CDH29A, ANASTOMOTIC LEAK (N=1), ILEUS (N=1), CDH25A, ANASTOMOTIC LEAK (N=1), ILEUS (N=1), 2. DOES THE SURGEON BELIEVE THAT WAS A RESULT OF EITHER OF THE ETHICON DEVICES? CDH29A, ANASTOMOTIC LEAK (N=1), ILEUS (N=1), CDH25A, ANASTOMOTIC LEAK (N=1), ILEUS (N=1). 3. PLEASE PROVIDE FURTHER DETAIL. IS IT KNOWN WHETHER OR NOT THE ISSUES NOTED WERE PREVIOUSLY REPORTED TO ETHICON CUSTOMER QUALITY? 4. IF YES, DO YOU HAVE THE PRODUCT COMPLAIN SUBMISSION RECORD NUMBERS? ADDITIONAL INFORMATION CANNOT BE OBTAINED. 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: ANALYSIS OF THE CLINICAL EFFECT OF LAPAROSCOPIC COLORECTAL CANCER RADICAL SURGERY AUTHORS: WANG LICHUN1, WANG WENDA1, LIU SHIZHOU2 CITATION: CHINA CLIN PRAC MED (DECEMBER 2020), VOL.11, NO.6. DOI: 10.3760/CMA.J.CN115570-20200324.00373. THE AIM OF THIS RETROSPECTIVE STUDY IS TO INVESTIGATE THE CLINICAL EFFECT OF LAPAROSCOPIC COLORECTAL CANCER RADICAL SURGERY. FROM AUGUST 2018 TO MAY 2019, A TOTAL OF 64 COLORECTAL CANCER PATIENTS (37 MALES AND 27 FEMALES; AGED 52.71 ± 2.68 YEARS [RANGING FROM 33 TO 72 YEARS) WERE INCLUDED IN THE STUDY. PATIENTS WERE DIVIDED INTO LAPAROSCOPIC GROUP (N=30; 17 MALES AND 13 FEMALES, AGED 55.26 ± 2.33 YEARS) AND THE TRADITIONAL LAPAROTOMY GROUP (N=34; 20 MALES AND 14 FEMALES, AGED 53.87 ± 3.12 YEARS). LAPAROSCOPIC COLORECTAL CANCER RADICAL SURGERY (LCS) WAS PERFORMED IN THE LAPAROSCOPIC GROUP USING THE FOLLOWING: JOHNSON & JOHNSON MEDICAL DEVICE CO., LTD., MODEL ACE36E-HAR36 TO EXPLORE THE ABDOMINAL CAVITY UNDER LAPAROSCOPE ACCORDING TO THE PRINCIPLE OF "FROM FAR TO NEAR", AN ULTRASONIC SCALPEL (ETHICON ENDOSCOPIC SURGERY INSTRUMENTS CO., LTD., MODEL ACE-HARH36) TO DISSECT THE PERITONEUM, MESENTERY AND OTHER TISSUES AND PERFORM MESENTERY RESECTION, LIGATE THE ARTERY AND VEIN AT THE ROOT, MAKE A LONGITUDINAL INCISION ABOUT 5 CM IN LENGTH ACCORDING TO THE TUMOR LOCATION IN THE ABDOMINAL WALL AND REMOVE THE DISEASED INTESTINAL CANAL, AND USE A STAPLER (ETHICON ENDOSCOPIC SURGERY INSTRUMENTS CO., LTD., MODEL CDH29A/CDH25A; KE HUI CO., LTD., MODEL EEA28) TO PERFORM SIDE-TO-SIDE ANASTOMOSIS AFTER RESECTION OF THE LESION. THE TRADITIONAL LAPAROTOMY GROUP UNDERWENT OPEN RADICAL RESECTION OF COLORECTAL CANCER (OCR). REPORTED COMPLICATIONS INCLUDE ANASTOMOTIC LEAK (N=1) AND ILEUS (N=1). IN CONCLUSION, LAPAROSCOPIC RADICAL RESECTION OF COLORECTAL CANCER NOT ONLY HAS A SIGNIFICANT THERAPEUTIC EFFECT, BUT ALSO CAN EFFECTIVELY REDUCE THE INCIDENCE OF COMPLICATIONS, AND HAS HIGH SAFETY AND EFFECTIVENESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143317 ILS 25MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention