BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 16643912 · Received March 30, 2023

    Report

    Report Number
    3005075853-2023-02100
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    May 7, 2022
    Report Date
    March 30, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: PERI-OPERATIVE MORBIDITY OF NISSEN SLEEVE GASTRECTOMY: PROSPECTIVE EVALUATION OF A COHORT OF 365 PATIENTS, BEYOND THE LEARNING CURVE. AUTHOR(S): DAVID NOCCA, FLORENCE GALTIER, SULAIMAN TALEB, MARIE-CHRISTINE PICOT, AUDREY JAUSSENT, MARTA SILVESTRI, PATRICK LEFEBVRE, AUDREY DE JONG, THOMAS GAUTIER, MARCELO LOUREIRO, MARIUS NEDELCU. CITATION: OBESITY SURGERY (2022) 32:2148¿2154; HTTPS://DOI.ORG/10.1007/S11695-022-06066-0. THE CURRENT STUDY REPORTS THE PRELIMINARY RESULTS OF A PROSPECTIVE TRIAL WITH NISSEN-SLEEVE GASTRECTOMY. BETWEEN JANUARY 1, 2018, AND SEPTEMBER 30, 2020, 365 PATIENTS WHO UNDERWENT A NISSEN-SLEEVE GASTRECTOMY WERE INCLUDED IN THE STUDY. 75 PERCENT WERE FEMALES, AND THE MEDIAN AGE WAS 41.2 YEARS (+ /- 14.1). THE AVERAGE BMI WAS 41.6 KG/M2 (+ /- 5.4). ALL OPERATIONS WERE PERFORMED UNDER GENERAL ANESTHESIA AND BY A LAPAROSCOPIC APPROACH USING THE FRENCH TECHNIQUE. THE GASTRIC DISSECTION PROCEDURE WAS PERFORMED USING THE HARMONIC ACE (ETHICON ENDO-SURGERY). IN CASES OF A HIATAL HERNIA, AFTER THE DISSECTION AND REDUCTION, THE HIATAL ORIFICE WAS CLOSED POSTERIORLY USING 1 TO 3 NON-ABSORBABLE INTERRUPTED SUTURES 2.0 OF ETHIBOND (ETHICON). A COMPETITOR A 37F TUBE (MANUFACTURER: MEDICAL INNOVATION DEVELOPMENT) WAS THEN INTRODUCED INTO THE STOMACH. A 3.0 ETHIBOND SUTURE (ETHICON) WAS USED TO CREATE A NISSEN FUNDOPLICATION OF 3 CM. A LAPAROSCOPIC ECHELON LINEAR STAPLER WITH GREEN CARTRIDGES (ETHICON ENDO-SURGERY) REINFORCED BY A COMPETITOR BIO-ABSORBABLE STAPLE LINE (MANUFACTURER: WL GORE, USA) WAS INTRODUCED INTO THE PERITONEAL CAVITY AND APPLIED ALONGSIDE THE 37F TUBE. ALL PATIENTS RECEIVE PERI-OPERATIVE DEEP VEIN THROMBOSIS PROPHYLAXIS USING LOW MOLECULAR WEIGHT HEPARIN (40 MG × 2/ DAY) AND INTERMITTENT PNEUMATIC LEG COMPRESSION DURING THE OPERATION AND RECOVERY. ROUTINE VITAL SIGNS ARE RECORDED AND NOTABLE CHANGES, INCLUDING FEVER > 38.5°, SUSTAINED TACHYCARDIA ABOVE 100 BPM OR ATYPICAL PAIN ARE PROMPTLY EVALUATED FOR POSSIBLE COMPLICATIONS. PATIENTS ARE ALSO CLOSELY MONITORED FOR POSTOPERATIVE RESPIRATORY COMPLICATIONS INCLUDING HYPOXEMIA, HYPERCARBIA, ATELECTASIS, AND PNEUMONIA. THE REPORTED COMPLICATIONS INCLUDED INTRAOPERATIVE BLEEDING AT THE LEVEL OF THE SPLEEN (N=2), ACUTE WRAP PERFORATION OCCURRED LESS THAN 30 DAYS POSTOPERATIVE (N=6), INTRAABDOMINAL BLEEDING (N=5), WRAP PERFORATION AFTER THE MANAGEMENT OF HEMORRHAGE (N=2), WRAP DILATATION AT POSTOPERATIVE DAY 2 LEADING TO ISCHEMIA OF THE WRAP (N=1), ACUTE COMPLETE APHAGIA (N=1), INCARCERATED UMBILICAL HERNIA (N=1), MILD DYSPHAGIA (N=16), CHRONIC DYSPHAGIA AND A FAILURE OF FUNDOPLICATION (N=3), WRAP PERFORATION AT 8 AND 9 POSTOPERATIVELY (N=2). IN CONCLUSION, FOLLOWING THE INITIAL LEARNING CURVE AND ADDITIONAL TECHNICAL MODIFICATIONS, THE NISSEN-SLEEVE APPEARS TO BE A SAFE SURGICAL TECHNIQUE WITH AN ACCEPTABLE EARLY POSTOPERATIVE COMPLICATION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591448 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention