BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22373651 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04961
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    November 5, 2021
    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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2021. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS 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 MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. 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 "IT SEEMS TO ME THAT YOU / YOUR TEAM HAS NOT READ MY ARTICLE PROPERLY. THE MAIN OUTCOME MEASURE WAS TIME TAKEN TO CLOSE THE VAGINAL VAULT LAPAROSCOPICALLY USING BARBED OR POLYGALACTIN SUTURE. COMPLICATION RATE WAS NOT THE MAIN OUTCOME OF THE STUDY. THE STUDY WAS NOT POWERED TO STUDY THE COMPLICATION RATES USING THESE TWO DIFFERENT SUTURES. MOREVOER COMPLICATIONS WERE VERY FEW AND THERE WAS NO DIFFERENCE IN THE COMPLICATION RATES BETWEEN THESE TWO SUTURES. I THINK THAT ANSWERS THE QUESTION. I WOULD NOT LIKE TO ADD ANYTHING OTHER THAN THIS." 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: BARBED SUTURE VERSUS POLYGLACTIN SUTURE FOR LAPAROSCOPIC CLOSURE OF VAGINAL VAULT AFTER TOTAL LAPAROSCOPIC HYSTERECTOMY: A PROSPECTIVE OBSERVATIONAL COMPARISON AUTHORS: PRIYA SUSAN MATHEW, MBBS, SHASHANK SHEKHAR, MD, DNB, FMAS, MAISHA JHIRWAL, MD, FMAS, MANU GOYAL, MD, DNB, FMAS, PRATIBHA SINGH, MD, FMAS, AND CHARU SHARMA, DGO, MS, FMAS CITATION: JOURNAL OF GYNECOLOGIC SURGERY (2021); 37(5):419-423. DOI: 10.1089/GYN.2020.0229. THE AIM OF THIS PROSPECTIVE OBSERVATIONAL STUDY IS TO ASSESS THE EASE OF VAGINAL CUFF CLOSURE WITH BARBED SUTURE AND POLYGLACTIN SUTURE IN TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH). A TOTAL OF 120 WOMEN WHO UNDERWENT TLH FOR BENIGN CONDITIONS FROM DECEMBER 2018 TO JUNE 2020 WERE INCLUDED. COLPOTOMY WAS PERFORMED WITH HARMONIC® SCALPEL SHEARS (ETHICON ENDO-SURGERY), TAKING SUPPORT OVER THE VAGINAL COLPOTOMIZER RING FOR DEFINING CERVICOVAGINAL JUNCTION. VAGINAL CUFF CLOSURE WAS PERFORMED LAPAROSCOPICALLY WITH EITHER COMPETITOR'S UNIDIRECTIONAL BARBED SUTURE (N=55) OR WITH POLYGLACTIN SUTURE (1-0 POLYGLACTIN; ETHICON, N=65). THE MEAN AGE OF THE PATIENTS IN POLYGLACTIN SUTURE AND BARBED SUTURE WERE 44.6 (SD 5.1) YEARS AND 45.2 (SD 6.0) YEARS, RESPECTIVELY. REPORTED COMPLICATIONS INCLUDE VAGINAL BLEEDING (N=2) 1 ON EACH GROUP, VAGINAL CUFF GRANULOMA (N=3), AND VAULT INFECTION (N=2). IN CONCLUSION, BARBED SUTURE MAKES LAPAROSCOPIC VAGINAL CUFF CLOSURE FASTER WITHOUT ANY INCREASE IN THE RATE OF POSTOPERATIVE COMPLICATIONS. HENCE IT CAN BE AN EFFECTIVE ALTERNATIVE OVER POLYGLACTIN FOR VAGINAL CUFF CLOSURE IN TLH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262050 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention GENERATOR