BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 ART STRA SEALER 35CM

    MDR report key: 22073390 · Received May 22, 2025

    Report

    Report Number
    3005075853-2025-03890
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    May 13, 2025
    Report Date
    May 22, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    UDI-DI
    10705036014515
    PMA / PMN Number
    K122797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/22/2025 D4 BATCH #: UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ¿ PLEASE EXPLAIN WHERE THE NSLG2S35A WAS BROKEN THE JAWS WILL NOT OPEN AND CLOSE WHEN OPERATED. ¿ DID THE ELECTRODE CERAMIC SEPARATE OR BREAK OFF? NOT SURE ¿ 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? NO. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAWS OF IT WILL NOT OPEN AND CLOSE WITH THE HANDLE. SOMETHING CAME BROKEN IN IT. NEW DEVICE WAS OPENED. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320526 ENSEAL G2 ART STRA SEALER 35CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. C9E791 10705036014515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GENERATOR