BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 21826136 · Received April 11, 2025

    Report

    Report Number
    3005075853-2025-02647
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    January 1, 2024
    Report Date
    July 17, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 05/06/2025. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 04/11/25. D4: BATCH # UNK. B3: ONLY EVENT YEAR KNOWN: 2024. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. H4: THE DEVICE MANUFACTURE DATE IS CURRENTLY NOT AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: AFTER FURTHER RESEARCH WE HAVE RETRIEVED THE FOLLOWING ADDITIONAL INFORMATION: DR. AUKEMA SPOKE OF A TRIPLING / QUADRUPLING OF THE INCIDENCE OF THIS TYPE OF BLEEDING. IN 2024, 181 COLORECTAL PROCEDURES WERE PERFORMED, 7 OF WHICH HAD SECONDARY BLEEDING. 2 OF THESE RESOLVED SPONTANEOUSLY, 5 REQUIRED REOPERATION AND RESULTED IN A SUTURE LEAKAGE THE BLEEDING OCCURRED IN BOTH THE RIGHT HEMI, LEFT SIGMOID/LAR. 4X IN THE RIGHT HEMI AND IN BOTH MALIGNANT AND BENIGN. IN THE RIGHT HEMI IT COULD BE THAT ONE OR MORE PROCEDURES WERE EXTRACORPOREALLY STAPLED WITH NTLC, FOR THE REST POWERED PLUS WAS USED THE SPECIALISTS DID NOT HAVE A HYPOTHESIS AS TO WHAT EXACTLY COULD HAVE CAUSED IT, BUT IT WAS CLEAR TO THEM THAT THE BLEEDING RESULTED IN SUTURE LEAKAGE BLUE FILLING IS USED FOR THE RIGHT HEMI, BLUE OR GOLD HEMI LEFT, OFTEN GOLD FOR THE SIGMOID AND GREEN RECTUM. NO LOT OR BATCH NUMBER WAS PROVIDED; THEREFORE, A DEVICE HISTORY COULD NOT BE DONE. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/17/2025. CORRECTED DATA: B1, B2 AND H1.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 05/30/2025. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ARE THESE ANASTOMOTIC LEAKS OR POST-OP BLEEDS? POST-OP BLEEDS, RESULTING IN ANASTOMOTIC LEAKS WHAT IS THE PRODUCT CODE? PSEE60A, NTLC, CDH29P. WAS THE BLEEDING INTRALUMINAL OR EXTRALUMINAL? INTRALUMINAL. CORRECTED DATA: D1, D2A, D4 (CATALOG), G1 (MANUFACTURING SITE NAME AND ADDRESS).

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 7/17/2025. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE A RESPONSE HAS NOT BEEN RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. HOW WERE THE LEAKS AND BLEEDS RELATED? WAS A LEAK TEST PERFORMED? IF SO, WHAT TYPE AND WHAT WAS THE RESULT? WAS THE STAPLE LINE VISUALIZED ENDOSCOPICALLY DURING THE INITIAL SURGICAL PROCEDURE? HOW MANY DAYS POSTOPERATIVE DID THE LEAK OCCUR? HOW WAS THE LEAK IDENTIFIED? WHAT WAS OBSERVED AT THE SITE OF THE LEAK UPON REOPERATION? HOW WAS THE LEAK ADDRESSED? WERE THERE ANY ISSUES EXPERIENCED WITH THE DEVICE IN THE INITIAL SURGICAL PROCEDURE? DOES THE SURGEON BELIEVE THE POST-OPERATIVE LEAK WAS RELATED TO AN ALLEGED DEFICIENCY OF THE DEVICE? PLEASE EXPLAIN. WERE THERE OTHER CONTRIBUTING PATIENT FACTORS? PLEASE EXPLAIN. PLEASE PROVIDE A TIMELINE OF EVENTS. WERE THERE ANY SPECIFIC DIAGNOSTIC OR THERAPEUTIC TAKEN TO ADDRESS THE ANASTOMOTIC BLEEDING? WHAT IS THE ESTIMATED COLORECTAL PROCEDURES VOLUMES AT THE HOSPITAL?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POST OP TO A COLORECTAL PROCEDURE THERE WAS INTRALUMINAL BLEEDING WITH THE STAPLER. LED TO AN ANASTOMOTIC LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081054 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention