BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL

    MDR report key: 24832934 · Received April 9, 2026

    Report

    Report Number
    3005075853-2026-02704
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    November 13, 2025
    Report Date
    April 9, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/9/2026. B3: PUBLICATION YEAR OF 2025. 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: HANY M, ZIDAN MH, ELHADIDY MS, ABOUELNASR AA, EL SHAFEI MM, MATRAWY K, KASSEM AM, HAMDY A, ELMONGUI E, EL-RAMLY TA, GHARRAF H, HOZIEN AI, MEKKY J. ANATOMICAL REMODELING OF THE UPPER AIRWAY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY: A MULTIMODAL ASSESSMENT OF STRUCTURAL AND FUNCTIONAL IMPROVEMENTS IN OBSTRUCTIVE SLEEP APNEA. OBES SURG. 2025 DEC;35(12):5316-5335. DOI: 10.1007/S11695-025-08352-Z. EPUB 2025 NOV 13. PMID: 41231327; PMCID: PMC12722346. THIS PROSPECTIVE STUDY AIMS TO ASSESS THE IMPACT OF SG ON OSA, UTILIZING MAGNETIC RESONANCE IMAGING (MRI) AND POLYSOMNOGRAPHY TO ANALYZE STRUCTURAL CHANGES AND CLINICAL OUTCOMES. BETWEEN MAY 2023 TO JANUARY 2024, A TOTAL OF 40 PATIENTS DIAGNOSED WITH OBSTRUCTIVE SLEEP APNEA (OSA) UNDERWENT SLEEVE GASTRECTOMY (SG ) USING ENSEAL DEVICE (ETHICON ENDO-SURGERY, CINCINNATI, OH, USA) AND ECHELON FLEX ENDOPATH 60-MM LINEAR STAPLER (ETHICON ENDO-SURGERY, CINCINNATI, OH, USA). REPORTED COMPLICATIONS ARE: ENSEAL, ECHELON FLEX ENDOPATH. N=? INTRAOPERATIVE TRANSIENT HYPOTENSION, TREATMENT: VASOPRESSOR ADMINISTRATION. N=? INTRAOPERATIVE OXYGEN DESATURATION, TREATMENT: VENTILATORY ADJUSTMENTS. N=? SUPERFICIAL WOUND INFECTIONS, TREATMENT: MANAGED CONSERVATIVELY. IN CONCLUSION, THIS PROSPECTIVE STUDY SUGGESTS THAT SG CAN PRODUCE MEANINGFUL SHORT-TERM IMPROVEMENTS IN OSA SEVERITY AND RELATED COMORBIDITIES IN PATIENTS WITH OBESITY. THESE BENEFITS APPEAR TO BE DRIVEN BY BOTH SUBSTANTIAL WEIGHT LOSS AND ANATOMICAL REMODELING OF THE UPPER AIRWAY. INTERESTINGLY, THE EXTENT OF WEIGHT LOSS WAS NOT SIGNIFICANTLY CORRELATED WITH INDIVIDUAL IMPROVEMENTS IN SLEEP FUNCTION, INDICATING THE MULTIFACTORIAL NATURE OF OSA RESPONSE. SG WAS ALSO ASSOCIATED WITH COMPLETE RESOLUTION OF DAYTIME SLEEPINESS AND REDUCED CPAP RELIANCE, IN ADDITION TO METABOLIC IMPROVEMENTS SUCH AS REMISSION OF DIABETES AND HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885736 ENSEAL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention