BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 18920343 · Received March 18, 2024

    Report

    Report Number
    3005075853-2024-02209
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    January 1, 2023
    Report Date
    March 18, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)/ DATE SENT: 3/18/2024 B3: PUBLICATION YEAR OF 2023 D4: 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.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 4/8/2024 ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN NO. H1 UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE.

    Description of Event or Problem · 0

    TITLE: CLOSURE OF CHOLEDOCHOTOMY WITH A BARBED ABSORBABLE SUTURE AFTER LAPAROSCOPIC COMMON BILE DUCT EXPLORATION AUTHORS: JISHENG ZHU, MD1, YANG ZHANG, MD1, JIEWEN GONG, MD1, WEIDONG XIAO, MD, PHD1, AND YONG LI, MD1 CITATION: THE AMERICAN SURGEON¿ 2023; 89(4):1173¿1174. DOI: 10.1177/0003134820982861. THE AIM OF THIS STUDY IS TO DESCRIBE THE SHORT- AND MEDIUM-TERM RESULTS OF PRIMARY CLOSURE WITH BARBED SUTURE FOLLOWING LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (LCBDE). BETWEEN (B)(6) 2016 TO S(B)(6) 2019, A TOTAL OF 221 PATIENTS WHO UNDERWENT LAPAROSCOPIC CHOLEDOCHOTOMY PLUS PRIMARY CLOSURE USING BARBED SUTURES WERE INCLUDED. THE MEAN AGE WAS 54.4 YEARS, AND 131 PATIENTS (59.3%) WERE WOMEN. THE AVERAGE CBD DIAMETER WAS 13.9 ± 3.8 MM; 2.1 ± 1.3 STONES WERE REMOVED FROM THE CBD. THE ADHESION AROUND THE GALLBLADDER WAS SEPARATED BY A HARMONIC SCALPEL (ETHICON, USA) TO EXPOSE THE CALOT¿S TRIANGLE. THE CBD INCISION WAS PRIMARILY CLOSED WITH 4-0 STRATAFIX SPIRAL POLYDIOXANONE (ETHICON) CONTINUOUS SUTURE. THE FOLLOW-UP PERIOD LASTED UP TO JULY 31, 2020, AND THE MEAN FOLLOW-UP WAS 28.2 MONTHS. REPORTED COMPLICATIONS INCLUDE INTRAOPERATIVE BLEEDING (N=1) REQUIRING CONVERSION TO OPEN SURGERY AND POSTOPERATIVE INTRA-ABDOMINAL BLEEDING (N=1). IN CONCLUSION, PRIMARY CLOSURE WITH BARBED SUTURE FOLLOWING LCBDE IS A SAFE AND EFFECTIVE TREATMENT FOR THE MANAGEMENT OF CBD STONES IN SELECTED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185167 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention