BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL GENERIC PRODUCT CODE

    MDR report key: 23098075 · Received September 19, 2025

    Report

    Report Number
    3005075853-2025-07462
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    March 1, 2025
    Report Date
    September 19, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 9/19/2025 B3: PUBLICATION YEAR OF 2024 D4: BATCH # UNK D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KATAPADI A, POTHINENI NVK, GOPINATHANNAIR R, KABRA R, ROMEYA A, LAKKIREDDY D, DARDEN D. REFRACTORY INAPPROPRIATE SINUS TACHYCARDIA POST SINUS NODE SPARING HYBRID THORACOSCOPIC ABLATION ORIGINATING FROM THE ARCUATE RIDGE. HEARTRHYTHM CASE REP. 2024 NOV 25;11(3):214-218. DOI: 10.1016/J.HRCR.2024.11.016. PMID: 40182946; PMCID: PMC11962985. THIS STUDY REPORTS A CASE OF A 27-YEAR-OLD WOMAN WITH LONGSTANDING SYMPTOMATIC IST WAS REFERRED TO OUR CENTER FOR SN SPARING HYBRID ABLATION. SHE HAD UNDERGONE AN ELECTROPHYSIOLOGY (EP) STUDY 2 YEARS PRIOR FOR CONTINUED SYMPTOMS OF PALPITATIONS, FATIGUE, AND DIZZINESS, FOR WHICH SHE UNDERWENT ABLATION OF A CONCEALED LEFT LATERAL ACCESSORY PATHWAY WITH NO INDUCIBLE TACHYCARDIA AT THAT TIME. SHE WAS TAKEN TO THE HYBRID EP LABORATORY, WHERE SHE WAS NOTED TO HAVE SINUS TACHYCARDIA WITH AN HR OF 105 BEATS/MIN UNDER GENERAL ANESTHESIA. A 3-PORT THORACOSCOPIC APPROACH WAS USED TO ACCESS THE PERICARDIUM, WHICH WAS OPENED WITH THE ENSEAL X1 TISSUE SEALER DEVICE (ETHICON, RARITAN, NJ). REPORTED COMPLICATIONS ARE N=1; 27-YEAR-OLD; FEMALE NO IMPROVEMENT IN SYMPTOMS AS SHE BEGAN AMBULATING PERSISTENT DEBILITATING SYMPTOMS TREATMENT: REPEAT ABLATION. IN CONCLUSION, IN PATIENTS WITH IST REFRACTORY TO MEDICATION, SN SPARING HYBRID ABLATION RESULTS IN FAVORABLE OUTCOMES, WHILE AVOIDING THE NEED FOR A PPM. IN CERTAIN PATIENTS, THE AR MAY ALSO BE A SOURCE OF IST. IN THESE PATIENTS, A DETAILED BASELINE EP STUDY GUIDED BY ICE IS BENEFICIAL IN DETERMINING SN VS AR ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760913 ENSEAL GENERIC PRODUCT CODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention