BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 16643747 · Received March 30, 2023

    Report

    Report Number
    3005075853-2023-02097
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    August 12, 2022
    Report Date
    March 30, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2022. BATCH # UNK. 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

    TITLE: LONG-TERM OUTCOMES OF LAPAROSCOPIC GASTRIC PLICATION FOR TREATMENT OF MORBID OBESITY: A SINGLE-CENTER EXPERIENCE. AUTHOR: MOHAMED ABDELGAWAD · AHMED ELGEIDIE · MOHAMED EL SOROGY · MOHAMED ELREFAI · HOSAM HAMED · EL-SAYED ABOU EL-MAGD. CITATION: OBESITY SURGERY (2022) 32:3324¿3331 HTTPS://DOI.ORG/10.1007/S11695-022-06217-3. THIS STUDY WAS CONDUCTED TO ELUCIDATE THE LONG-TERM CONSEQUENCES OF LAPAROSCOPIC GASTRIC PLICATION (LGP). RETROSPECTIVE ANALYSIS OF PATIENTS WITH OBESITY UNDERWENT LGP AT OUR INSTITUTION BETWEEN MARCH 2010 AND SEPTEMBER 2014. OF THE 88 CONSECUTIVE PATIENTS IN THE STUDY, FOLLOW-UP DATA OUT TO 6 YEARS WAS AVAILABLE IN 60 LGP PATIENTS. THE MEAN AGE OF THE INCLUDED PATIENTS WAS 41.3 ± 10 YEARS. HARMONIC DEVICES WAS USED FOR DEVASCULARIZATION. PROLENE AND/OR ETHIBOND SUTURES WERE USED FOR PLICATION. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: (N=5) NAUSEA, VOMITING AND EPIGASTRIC PAIN. (N=?) DE NOVO GERD. (N=4) EROSIVE ESOPHAGITIS, 3 OF THEM HAD GRADE A REFLUX ESOPHAGITIS, AND THE OTHER ONE HAD GRADE B REFLUX ESOPHAGITIS. (N=1) MAJOR COMPLICATION AND REQUIRED EMERGENCY REOPERATION DUE TO EARLY LEAKAGE FROM THE PROXIMAL ONE-THIRD OF THE PLICATED GASTRIC FUNDUS. (N=13) REOPERATIONS. IN CONCLUSION, AT THE 6-YEAR FOLLOW-UP VISIT, LGP HAS A MUCH LESS DURABLE EFFECT ON WEIGHT LOSS WITH A % EWL OF 32% AND A WEIGHT REGAIN OF 58.3% RESULTING IN A HIGH RATE OF REVISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226465 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention