BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX 45 COMPACT

    MDR report key: 21405226 · Received February 18, 2025

    Report

    Report Number
    3005075853-2025-01251
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    February 5, 2025
    Report Date
    March 26, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036002697
    PMA / PMN Number
    K051002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 02/18/25 D4: BATCH #UNK. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE SC45A WITH LOT NUMBER 255D47; AND NO NON-CONFORMANCES WERE IDENTIFIED. 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: 3/26/2024. D4: BATCH # 159D84. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON ENDO-SURGERY FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE SC45A DEVICE WAS RETURNED WITH NO APPARENT DAMAGE AND WITH A GST45W RELOAD PRESENT. THE RELOAD WAS RECEIVED PARTIALLY FIRED 1/10 AND THE RELOAD PAN WAS NOTED TO BE PARTIALLY DISLODGED FROM RIGHT PROXIMAL SIDE AND DAMAGED ON SAME AREA. IT IS ALSO POSSIBLE THAT HANDLING BY THE CUSTOMER COULD DISLODGE THE PAN. DISLODGEMENT AS A RESULT OF THE REMOVAL OF THE RELOAD FROM THE DEVICE IS THE MOST LIKELY SCENARIO. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. THE RETURNED DEVICE AND A TEST RELOAD WERE TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE REMAINING STAPLES MEET THE STAPLE FORM RELEASE CRITERIA. THE EVENT REPORTED OF REPORTED TISSUE TRAUMA- INTERVENTION REQUIRED AND WOULD NOT FIRE WAS CONFIRMED AND IT IS RELATED TO IMPROPER USE OF THE DEVICE. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE RELOAD WAS PUSHED FARTHER BACK THAN THE RELOAD ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE-PIECE SLED FORWARD AND LOCKING THE RELOAD. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. THE EVENT OF WOULD NOT OPEN COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 159D84, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LIVER RESECTION PROCEDURE, THE DEVICE HAD BEEN FIRED 3 PREVIOUS TIMES WITHOUT ISSUE THEN IT WOULDN'T FIRE OR OPEN TO REPOSITION OR JUST REMOVE THE DEVICE ON THE 4TH FIRE ATTEMPT. THE DEVICE GOT STUCK ON THE SPECIMEN TISSUE AS HE USED ANOTHER ENDOCUTTER, PVE35A TO SUCCESSFULLY TRANSECT NEXT TO THIS ENDOCUTTER FOR THE LAST FIRE, WHEN THE DEVICE WAS HANDED TO THE SCRUB TECH STILL ATTACHED TO THE SPECIMEN TISSUE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60173 ECHELON FLEX 45 COMPACT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 255D47 10705036002697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown