BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED 60 ECHELON +, 440MM SHAFT

    MDR report key: 16536592 · Received March 14, 2023

    Report

    Report Number
    3005075853-2023-01494
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    February 14, 2023
    Report Date
    March 14, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014614
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 03/31/2023.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/14/2023. BATCH # UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. 3RD CASE OF THE DAY, PATIENT BMI 49. 2. 60 MM ECHELON PLUS, GST RELOADS, AND GORE SEAMGUARD ON ALL FIRINGS. 3. FIRST 2 GREEN FIRINGS WITH GORE SEAMGUARD. A. NO ISSUES. 4. SURGEON ROUTINELY PULSE FIRES QUITE RAPIDLY ON ALL FIRINGS. 5. 3RD FIRING, GORE SEAMGUARD ON BOTH THE ANVIL AND CHANNEL, PULSED 1/4 OF THE WAY INTO THE FIRING, THEN THE JJM REP (LILLY) HEARD A SOFT, SUBTLE CLICK. A. SHE SAID TO THE SURGEON, "DID YOU HEAR THAT?". B. SURGEON COMPLETED THE FULL FIRING. 6. SURGEON OPENED THE DEVICE VERY SLOWLY AFTER HEARING JJM REP¿S QUESTION. 7. LIFTED WINGS OF BUTTRESS UP TO SEE THE STAPLES. 8. OUTER ROW OF STAPLES WAS FULLY FORMED SO NO RUSH OF BLOOD. A. INNER ROWS OF STAPLES WERE NOT FULLY FORMED ON ONE SIDE OF THE RELOAD. 9. SURGEON WAS ORIGINALLY GOING TO CONVERT TO BYPASS UNTIL HE NOTICED THE OUTER ROW WAS FULLY FORMED. A. DECIDED INSTEAD TO HAND-SEW THE REGION WITH INCOMPLETE STAPLES AND LEAK TEST INSTEAD, WHICH HE DID SUCCESSFULLY. 10. SWITCHED TO A DIFFERENT GUN AFTER THE DOPS EVENT FOR THE REST OF THE PROCEDURE. 11. TISSUE WASN'T UNUSUALLY THICK. A. HEARD NO EVIDENCE DEVICE WAS SLOWING DOWN OR STRUGGLING. TO FIRE THROUGH THE TISSUE, EVEN THOUGH THEY WERE PULSING. I. JJM REP SAID EVEN WHEN SURGEONS PULSE IN THICK TISSUE YOU. CAN STILL ROUTINELY HEAR THE GUN SLOW DOWN, BUT SHE HEARD NO EVIDENCE OF THE DEVICE SLOWING DOWN ON THE FIRING IN QUESTION. 12. THE SURGEON WAS QUITE WIDE LATERAL RELATIVE TO THE BOUGIE. SHE HAS OTHER CUSTOMERS WHO ROUTINELY GET CLOSE TO THE BOUGIE, BUT NOT THIS SURGEON. 13. THE SURGEON IS ROUTINELY METICULOUS ABOUT NOT ALLOWING THE WINGS OF EXTRA GORE MATERIAL TO BE FOLDED INTO THE STAPLE LINE AND SHE HAD NO REASON TO THINK THE FOLDING OF THE WINGS INTO THE STAPLE LINES WAS AN ISSUE IN THIS REPORTED FIRING. 14. THE SCRUB WAS USING A TALL CONTAINER FILLED WITH FLUID THAT EXTENDED UP PAST THE ARTICULATION JOINT TO SWISH THE DEVICE AFTER EVERY FIRING. WHEN PLACED IN THE CONTAINER, THE SCRUB WAS GIVING THE DEVICE A GOOD SWILL AFTER EVERY FIRING AND THEN CHECKING FOR LOOSE STAPLES WITHIN THE JAWS AFTERWARDS. 15. SHE LISTED BOTH GUNS USED IN THE COMPLAINT IN THE COMPLAINT DESCRIPTION, BUT THEN ONLY MAILED IN THE GUN THAT WAS USED DURING THE SUSPECTED DOPS FIRING. 16. SURGEON ALWAYS FIRES ANVIL UP. 17. SURGEON WAS SLIGHTLY ARTICULATED DURING THE DOPS FIRING. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED PLEE60A WITH LOT/BATCH NUMBER X95X15, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. 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: 4/26/2023 INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO ETHICON ENDO-SURGERY CINCINNATI FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE (B)(6) DEVICE WAS RETURNED WITH NO APPARENT DAMAGE WITH A GST60G RELOAD LOADED IN THE DEVICE. ADDITIONALLY, THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, THE LEFT SIDE OUTER ROW FULLY FIRED, AND THE LEFT TWO INNER ROWS PARTIALLY FIRED 1/4. UPON EVALUATION OF THE RELOAD, THE RELOAD BODY, ONE-PIECE SLED, AND SOME DRIVERS WERE NOTED TO BE DAMAGED. NO OBVIOUS DAMAGE TO THE RELOAD DECK WAS NOTED, WHICH SUGGESTS THE RELOAD, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. AS ADDITIONAL TESTING, THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES MEET THE STAPLE RELEASE CRITERIA. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THE DAMAGE TO THE ONE-PIECE SLED HAS BEEN CORRELATED TO THE DESIGN. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH ETHICON ENDO SURGERY¿S QUALITY SYSTEM. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 950A71, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PRIMARY SLEEVE GASTRECTOMY, USED, PLEE60A, 2 X GREEN GST60G RELOADS WITH 2 X SEAMGUARD (1BSGEC60A), BOTH STAPLE FIRINGS WERE COMPLETED WITH NO CONCERNS. 3RD FIRING WITH PLEE60A, GST60G & SEAMGUARD (1BSGEC60A) USED, THE DEVICE PULSE FIRES FAIRLY QUICKLY ON THIS RELOAD WHILE FIRING APPROX AT 1/3RD OF THE FIRING, A VERY SLIGHT CRUNCH WAS HEARD, EXTREMELY SOFT AND ONLY PICKED UP SLIGHTLY, UPON HEARING THE CRUNCH ASKED IF IT WAS HEARD, THERE WAS NO RESPONSE HOWEVER UPON OPENING THE DEVICE AFTER THE FIRING SEQUENCE HAD BEEN COMPLETED, THE JAWS WERE OPENED VERY SLOWLY AND VERY CAREFULLY REMOVED THE DEVICE AND 2 ROWS WERE FOUND OF UNFORMED STAPLES ON THE PATIENT SIDE, 1 SINGLE LINE WITH TWO LINES MISSING. GASTRIC BYPASS WAS BEING CONSIDERED, HOWEVER THE STAPLELINE WAS ABLE TO BE OVERSEWED, DID A LEAK TEST, NO LEAK OBSERVED. IT WAS DECIDED TO COMPLETE HIATEL HERNIA REPAIR. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756820 POWERED 60 ECHELON +, 440MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PLEE60A X95X15 10705036014614

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female GST60G.