BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 ART STRA SEALER 35CM

    MDR report key: 16976113 · Received May 22, 2023

    Report

    Report Number
    3005075853-2023-03457
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    January 1, 2023
    Report Date
    May 22, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    UDI-DI
    10705036014515
    PMA / PMN Number
    K122797
    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: 5/22/2023. B3: EVENT YEAR ONLY REPORTED: 2023. D4 BATCH #: UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE ELECTRODE CERAMIC SEPARATE OR BREAK OFF? NO. DID THE I BLADE GET DAMAGED OR BREAK OFF? NO. IS THE JAW DAMAGED BUT NOT BROKEN OFF? NO. IS THE TOP JAW LOOSE BUT NOT DETACHED? NO. IS THE TOP JAW PTC MATERIAL DAMAGED? NO. IS THE BLACK PTC IN THE UPPER JAW DETACHED? NO. IS THE TOP JAW BROKEN OFF THE OF THE DEVICE? YES. 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 LOT NUMBER, AND NO NON-CONFORMANCE 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: 6/22/2023. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE DEVICE WAS RETURNED WITH THE UPPER JAW DETACHED AND NOT RETURNED. ADDITIONALLY, IT WAS RETURNED THE TOP OF THE I-BLADE FRACTURED AND LIFTED. THE DEVICE WAS CONNECTED TO THE GENERATOR AND IT WAS RECOGNIZED. BECAUSE THE JAW WAS DETACHED NOT ALL FUNCTIONAL TESTING COULD BE PERFORMED WITH THE GENERATOR. A PROBABLE CAUSE OF THE DAMAGE COULD BE NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT. AS DESCRIBED IN THE IFU: DO NOT USE EXCESSIVE FORCE ON THE CLOSING HANDLE TO CLOSE THE JAWS; GRASP ONLY AS MUCH TISSUE AS WILL FIT BETWEEN THE JAWS WHERE THE CURRENT WILL PASS. GREATER AMOUNTS OF TISSUE REQUIRE MORE CLOSING HANDLE FORCE. EXCESSIVE FORCE COULD DAMAGE THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION: AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH X95Y3U, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/19/2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LIVER SURGERY THE JAWS BROKE. A NEW DEVICE WAS OPENED. THE PROCEDURE WAS DELAYED A FEW MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471218 ENSEAL G2 ART STRA SEALER 35CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NSLG2S35A X9609G 10705036014515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GENERATOR