BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22381911 · Received July 2, 2025

    Report

    Report Number
    3005075853-2025-05022
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    January 1, 2014
    Report Date
    July 2, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 7/2/2025. B3: PUBLICATION YEAR OF 2014. D4: BATCH # UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. 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 VIA JOURNAL ARTICLE: TITLE: TECHNICAL ASPECTS FOR MAKING SLEEVE GASTRECTOMY WITH TUBE THEORY. AUTHOR: J. DEL CASTILLO PEREZ. CITATION: OBES SURG (2014) 24:1136¿1378. DOI 10.1007/S11695-014-1292-0 . THE OBJECTIVE OF THIS STUDY IS TO REDUCE ASSOCIATED COMPLICATIONS WITH THE TECHNICAL CONSIDERATIONS OF THE ¿TUBE THEORY¿. A TOTAL OF 2,000 PATIENTS, ASSIGNED IN TWO HOMOGENOUS GROUPS, UNDERWENT SLEEVE GASTRECTOMY. IN GROUP 1 (1,120 PATIENTS), THE TRADITIONAL TECHNIQUE WAS PERFORMED AND IN GROUP 2 (980 PATIENTS), THE ¿TUBE TECHNIQUE THEORY¿ WAS DONE. THE ¿TUBE TECHNIQUE THEORY¿ WAS PERFORMED USING THE HARMONIC SCALPEL AND STAPLES JOHNSON GREEN, GOLD AND 2 BLUE/60MM. THE RESULTS IN GROUP 2 INCLUDED 3% REFLUX, 0.4% HEMATOMA, AND 0.2% ABSCESS. IN CONCLUSION, THE AUTHOR REPORTED THAT THE ¨TUBE TECHNIQUE RECOMMENDATIONS¨ HAS LOW COMPLICATION RATE AND IMPROVES THE QUALITY OF LIFE WITH GOOD TOLERANCE TO FOOD WITHOUT VOMITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143183 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR AND HANDPIECE