BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ECHELON CONTOUR CURVED CUTTER STAPLER

    MDR report key: 22361427 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04838
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    April 8, 2022
    Report Date
    June 30, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: WERE THE SYMPTOMS MENTIONED CAUSED BY AN ETHICON PRODUCT? IS THE CURRENT PATIENT STATUS KNOWN? WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? (EXTENDED HOSPITAL STAY, READMISSION, RE-OPERATION, ETC.). 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: INTRAOPERATIVE COLONIC IRRIGATION FOR LOW RECTAL RESECTIONS WITH PRIMARY ANASTOMOSIS: A FAIL-SAFE SURGICAL MODEL. AUTHOR(S): JONAS HERZBERG, SHAHRAM KHADEM, SALMAN YOUSUF GURAYA, TIM STRATE AND HUMAN HONARPISHEH. CITATION: FRONT. SURG. 9:821827; DOI: 10.3389/FSURG.2022.821827. THIS STUDY AIMS TO ASSESS THE SHORT-TERM OUTCOME OF A MULTIDISCIPLINARY APPROACH TO REDUCE THE RATES OF ANASTOMOTIC LEAKAGE USING A FAIL-SAFE-MODEL USING PREOPERATIVE AND INTRAOPERATIVE COLONIC IRRIGATION IN LOW RECTAL RESECTIONS WITH PRIMARY ANASTOMOSIS. BETWEEN JANUARY 2015 AND DECEMBER 2020, 92 PATIENTS WHO RECEIVED LOW RECTAL RESECTIONS FOR RECTAL CANCER WITH PRIMARY ANASTOMOSIS AND DIVERTING ILEOSTOMY WERE INCLUDED IN THE STUDY. THERE WERE 61 MALES AND 31 FEMALES WITH A MEAN AGE OF 64.4 ± 11.66 YEARS. ALL THESE PATIENTS RECEIVED PRE-OPERATIVE MECHANICAL BOWEL PREPARATION WITHOUT ANTIBIOTICS AS WELL AS INTRAOPERATIVE COLONIC IRRIGATION. THERE WERE 88 PATIENTS WHO UNDERWENT THE LAPAROSCOPIC RESECTION PROCEDURE IN WHICH THE DISSECTION AND RESECTION OF THE RECTUM BELOW THE TUMOR WAS PERFORMED USING A COMPETITOR LINEAR STAPLER (MANUFACTURER: MEDTRONIC). MEANWHILE, 4 PATIENTS UNDERWENT OPEN RESECTION PROCEDURE IN WHICH THE TRANSECTION OF THE RECTAL SPECIMEN WAS DONE USING AN ECHELON CONTOUR DEVICE (ETHICON ENDO-SURGERY). THE ANASTOMOSIS WAS PERFORMED INTRACORPORIALLY USING A TRANSANALLY INTRODUCED CIRCULAR STAPLING DEVICE (MANUFACTURER: MEDTRONIC). AFTERWARDS, A SOFT DRAINAGE TUBE (MANUFACTURER: UNKNOWN) WAS PLACED INTRACORPOREALLY NEAR THE SITE OF ANASTOMOSIS. ON THE 4TH POSTOPERATIVE DAY, AN ENDOSCOPY WAS PERFORMED TO CONFIRM THE ANASTOMOTIC INTEGRITY AND THEN THE SOFT DRAINAGE TUBE WAS REMOVED. THE REPORTED COMPLICATIONS INCLUDED PROLONGED PARALYSIS (N=?), SURGICAL SITE INFECTION (N=?), AND POSTOPERATIVE BLEEDING (N=?). IN CONCLUSION, THIS STUDY VALIDATES THE EFFECTIVENESS OF A MULTI-DISCIPLINARY FAIL-SAFE MODEL WITH A PRE-OPERATIVE MECHANICAL BOWEL PREPARATION AND AN INTRAOPERATIVE COLONIC IRRIGATION IN REDUCING ANASTOMOTIC LEAKAGE RATES. INTRAOPERATIVE COLONIC IRRIGATION IS A FEASIBLE APPROACH THAT LOWERS THE ANASTOMOTIC LEAKAGE RATES BY REDUCING FECAL LOAD AND BY DECONTAMINATION OF THE COLON AND ANASTOMOTIC REGION. OUR STUDY DOES NOT RECOMMEND A PRE-OPERATIVE ADMINISTRATION OF ORAL ANTIBIOTICS FOR COLORECTAL DECONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928240 UNK_ECHELON CONTOUR CURVED CUTTER STAPLER UNK_ECHELON CONTOUR CURVED CUTTER STAPLER GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention