BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22373746 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04969
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 1, 2019
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2019. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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: OMENTOPEXY IN SLEEVE GASTRECTOMY REDUCES EARLY GASTROESOPHAGEAL REFLUX SYMPTOMS. AUTHORS: ANTONIO M.M. FILHO, MD; LYZ B. SILVA, MD; EDUARDO S. GODOY, MD; ANGELA M. FALCÃO, MD; LUIZ G. DE QUADROS, MD; IDIBERTO J. ZOTARELLI FILHO, MD; JOSEMBERG M. CAMPOS, PHD; LUCIO V. RABELO FILHO, PHD. CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH. 2019; 29: 155¿161. LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) IS ONE OF THE SURGICAL PROCEDURES INDICATED IN THE TREATMENT OF OBESITY. THE OBJECTIVES OF THE STUDY WAS TO EVALUATE THE PRESENCE OF GER SYMPTOMS, ALTERATIONS IN LOWER ESOPHAGEAL SPHINCTER (LES) TONE, AND THE PRESENCE OF RF IN OBESE SUBJECTS SUBMITTED TO LSG WITH OMENTOPEXY. A TOTAL OF 20 OBESE PATIENTS (18 FEMALE AND 2 MALE PATIENTS; AGE RANGE: 20 TO 60 YEARS OLD) WERE SUBMITTED TO LSG WITH OMENTOPEXY FROM JULY 2016 TO JULY 2017 AT THE HOSPITAL UNIMED DE TERESINA, BRAZIL AND WAS STUDIED PROSPECTIVELY. DURING THE PROCEDURE, THE ENTIRE GREAT CURVATURE WAS RESECTED, AS WAS THE GASTRIC FUNDUS UP TO 2.0 CM FROM THE ANGLE OF HIS AND 5 CM FROM THE PYLORUS USING A HARMONIC SCALPEL (ETHICON). AN ECHELON 60-MM LAPAROSCOPIC CUTTING STAPLER (ETHICON) WAS USED TO CREATE THE GASTRIC SLEEVE WITH 6 OR 7 CARTRIDGES (THE FIRST GREEN, THE SECOND GOLD, AND THE OTHERS BLUE). A 32 FOUCHET PROBE WAS USED FOR MOLDING, THEREBY PREVENTING STENOSIS. THE STAPLE LINE WAS REINFORCED WITH A CAPROFYL 3-0 CONTINUOUS SUTURE (ETHICON) WITH THE INITIAL STITCHES INVERTING THE MUCOSA. OMENTOPEXY WAS PERFORMED IN ALL CASES WITH THE AIM OF AVOIDING POSTOPERATIVE BLEEDING AND LATE FISTULAS, AND TO ANCHOR THE GASTRIC TUBE BETTER. REPORTED COMPLICATIONS INCLUDED LOWER ESOPHAGEAL SPHINCTER HYPOTONIA (N-4), HYPERTENSIVE LOWER ESOPHAGEAL SPHINCTER (N-2), AND RESIDUAL FUNDUS (N-3). LSG WITH OMENTOPEXY IMPROVED THE GERD SCORE IN MOST CASES. LSG WITH OMENTOPEXY DID NOT DETERMINE SIGNIFICANT CHANGES IN THE LES TONE; CHANGES IN LES HAD NO INFLUENCE ON CLINICAL COMPLAINTS RELATED TO GER. MOREOVER, THE PRESENCE OF RF DID NOT EXACERBATE THE CLINICAL GER SCORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270132 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention