BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 45 (EXACT CODE UNKNOWN)

    MDR report key: 22298848 · Received June 20, 2025

    Report

    Report Number
    3005075853-2025-04670
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    April 20, 2012
    Report Date
    June 20, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 6/20/2025 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? 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

    CHEN J, CHEN Z, PANG L, ZHU Y, MA Q, CHEN G, MIAO F. A MALFORMED STAPLE CAUSING CARDIAC TAMPONADE AFTER LOBECTOMY. ANN THORAC SURG. 2012 DEC;94(6):2107-8. DOI: 10.1016/J.ATHORACSUR.2012.04.128. PMID: 23176923. THIS IS A CASE STUDY OF 65-YEAR-OLD WOMAN WITH A 2-CM MASS IN THE LEFT UPPER LUNG WAS ADMITTED AFTER DRY COUGH AND LEFT CHEST PAIN FOR 2 MONTHS. SHE UNDERWENT LEFT UPPER LOBECTOMY AND LEFT LYMPHADENECTOMY SHORTLY AFTERWARDS WHILE USING ETS-FLEX 45 STAPLER (ETHICON ENDO-SURGERY). REPORTED COMPLICATIONS ARE N=1; 65-YEAR-OLD WOMAN RAPID DECLINE BLOOD PRESSURE 65/40MM. TREATMENT: NOT REPORTED SINUS TACHYCARDIA. TREATMENT: NOT REPORTED SUDDEN CHANGE OF THE COLOR OF THE CHEST FLUID. TREATMENT: NOT REPORTED 60ML OF FRESH BLOOD LIKE LIQUID WAS COLLECTED IN THE DRAINAGE CONTAINER. TREATMENT: NOT REPORTED PROGRESSIVE IRRITABILITY AND UNCONSCIOUSNESS. TREATMENT: NOT REPORTED BLOOD LOSS. TREATMENT: SENT TO THE OPERATING ROOM AND AN EMERGENCY THORACOTOMY WAS PERFOMED. IN CONCLUSION, WE PRESENT A PATIENT WITH CARDIAC TAMPONADE CAUSED BY A MALFORMED STAPLE AFTER LOBECTOMY. THE PATIENT WAS SUCCESSFULLY RESCUED BY AN URGENT REOPERATION. ALTHOUGH RARE, ACUTE CARDIAC TAMPONADE SHOULD BE TAKEN INTO ACCOUNT AFTER LOBECTOMY, AND PROPER MEASURES SHOULD BE TAKEN AGAINST THE POTENTIAL HARM CAUSED BY A MALFORMED STAPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202168 ECHELON 45 (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention