BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 3000 60MM LONG

    MDR report key: 17138427 · Received June 15, 2023

    Report

    Report Number
    3005075853-2023-04189
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 23, 2023
    Report Date
    July 14, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036034988
    PMA / PMN Number
    K213633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/15/2023 D4: BATCH # UNK ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: THIS WAS THE FIFTH FIRING OF THE CASE, BLUE RELOAD WITH SLR ON A NORMAL TISSUE FIRING I MISSED WHAT THE TISSUE STRUCTURE WAS, BUT HE CONFIRMED IT WAS NOT THICKER THAN USUAL ABOUT HALFWAY OR 2/3 OF THE WAY INTO THE FIRING THE DEVICE ¿STALLED¿ HE ATTEMPTED TO HIT THE HOME BUTTON AND NOTHING HAPPENED. HE IMMEDIATELY OPENED THE MANUAL BAILOUT AND TRIED TO USE THAT. HE SAID IT FELT DIFFICULT TO RATCHET BACK AND FORTH, AND IT¿S UNCLEAR HOW MANY TIMES HE RATCHETED IT O HE TRIED ANOTHER BATTERY AFTER TRYING MANUAL BAILOUT, BUT AS YOU KNOW THE POWER WON¿T WORK AT THAT POINT IN TIME THROUGH THE COURSE OF TRYING TO USE THE MANUAL BAILOUT, ATTEMPTING TO OPEN THE JAWS WITH THE NORMAL CLOSING TRIGGER AND ANVIL RELEASE, AND USING A SEPARATE INSTRUMENT WITHIN THE JAWS TO PUSH THEM OPEN HE WAS ABLE TO REMOVE THE DEVICE FROM TISSUE O THERE WAS NO IMPACT TO THE PATIENT OTHER THAN A SMALL DELAY IN SURGERY. SEPARATELY HE MENTIONED THAT HE FELT THE DEVICE WAS NOT HOMING STRAIGHT AND HIS THEORY IS THAT IT NOT BEING STRAIGHT WHEN BEING LOADED ONTO THE SLR APPLICATOR COULD HAVE CONTRIBUTED TO THE ISSUE 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: 7/14/2023. D4: BATCH # 127C57. 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 ECH60L DEVICE WAS RECEIVED WITH THE JAWS NOT FULLY OPEN, AND THE KNIFE WAS NOT IN THE HOME POSITION. AFTER THE DEVICE WAS CLOSED, THE BAILOUT LEVER WAS USED TO RETURN KNIFE ENTIRELY TO HOME POSITION. THE JAWS OPENED COMPLETELY AFTER THIS WITH NO DIFFICULTY. UPON DISASSEMBLY OF THE DEVICE, THERE WAS NO DAMAGE SEEN TO THE RELOAD OR KNIFE THAT MIGHT HAVE INTERFERED WITH THE BAILOUT MECHANISM. IN ADDITION, A GST60B RELOAD WAS RECEIVED PARTIALLY FIRED 3/4. 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. A REVIEW OF THE DEVICE EVENT LOG WAS CONDUCTED. A SOFTWARE ERROR WAS FOUND THAT CAUSED THE DEVICE TO DISABLE FIRING AND ARTICULATION FUNCTION AS A SAFETY MEASURE TO PREVENT ANY INADVERTENT HARM TO THE PATIENT. THE DEVICE CAN RECOVER FROM THIS STATE BY REINSERTING THE BATTERY. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH ETHICON ENDO SURGERY¿S QUALITY SYSTEM. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER127C57, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SLEEVE GASTRECTOMY PROCEDURE THAT THE DEVICE LOCKED DURING FIRING. SURGEON REMOVED BATTERY AND REINSERTED BATTERY INTO DEVICE. THE DEVICE DID NOT REVERSE KNIFE BLADE. THEY UTILIZED THE MANUAL OVERRIDE BUT THAT DID NOT WORK. THE SURGEON HAD TO PULL THE HANDLE IN ORDER TO OPEN THE DEVICE. NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047457 ECHELON 3000 60MM LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. ECH60L 127C57 10705036034988

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ECH60R.| GST60B.