BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL GENERIC PRODUCT CODE

    MDR report key: 23110136 · Received September 22, 2025

    Report

    Report Number
    3005075853-2025-07498
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    October 25, 2019
    Report Date
    September 22, 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: 9/22/2025. B3: PUBLICATION YEAR OF 2019. 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: BOMMAKANTI KK, MOSS WJ, WEISMAN RA, WEISSBROD PA. ZENKER'S DIVERTICULOTOMY WITH BIPOLAR TISSUE SEALER: RETROSPECTIVE REVIEW OF SAFETY AND SHORT-TERM OUTCOMES. AM J OTOLARYNGOL. 2020 JAN-FEB;41(1):102325. DOI: 10.1016/J.AMJOTO.2019.102325. EPUB 2019 OCT 25. PMID: 31727337. THE OBJECTIVE OF THIS RETROSPECTIVE STUDY IS TO ANALYZE AND REPORT THE INSTITUTION'S EXPERIENCE USING THE ENSEAL BIPOLAR TISSUE SEALING DEVICE TO PERFORM ENDOSCOPIC ZENKER'S DIVERTICULOTOMY. A TOTAL OF 19 PATIENTS (14 MALE AND 5 FEMALE; MEAN AGE WAS 71 YEARS) WITH ZENKER'S DIVERTICULUM (ZD) UNDERWENT ENDOSCOPIC DIVERTICULOTOMY WITH THE ENSEAL DEVICE BETWEEN 2011 AND 2019. THE ESOPHAGUS AND DIVERTICULUM WERE BLUNTLY PROBED AND THE DIVERTICULUM WAS DECOMPRESSED OF ANY ACCUMULATED FLUID OR DEBRIS. IF NEEDED, ONE OR TWO RETRACTION SUTURES WERE PLACED, AFTER WHICH THE ETHICON G2 ENSEAL WAS USED TO CUT AND SEAL THE CP MUSCLE AND COMMON PARTY WALL (FIG. 2). DEPENDING ON ZD SIZE AND ANATOMY, MULTIPLE ACTIVATIONS OF THE DEVICE WERE PERFORMED TO ENSURE A COMPLETE DIVISION. WHILE NOT RECORDED IN ALL CASES, THE DEVICE WAS TYPICALLY ACTIVATED 2¿4 TIMES FOR COMPLETE DIVERTICULOTOMY. THE AVERAGE LENGTH OF HOSPITAL STAY WAS 1.2 DAYS AND THE AVERAGE LENGTH OF FOLLOW-UP WAS 38 DAYS. REPORTED COMPLICATIONS INCLUDE RECURRENCE / OPERATIVE FAILURE (N=1). IN CONCLUSION, EVIDENCE FROM THIS PRELIMINARY STUDY OF ENDOSCOPIC ZENKER'S DIVERTICULOTOMY USING THE ENSEAL DEVICE INDICATES THAT IT IS BOTH SAFE AND EFFECTIVE. SEVERAL FEATURES OF THE DEVICE, INCLUDING ITS NARROW PROFILE, ARTICULATION AND ROTATION CAPABILITY, RAPID REPEATABLE ACTIVATION, AND LOW RISK OF COLLATERAL THERMAL INJURY, MAKE IT AN APPEALING OPTION FOR ENDOSCOPIC ZENKER'S DIVERTICULOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180881 ENSEAL GENERIC PRODUCT CODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention