BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 15041157 · Received July 18, 2022

    Report

    Report Number
    3005075853-2022-04639
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    May 4, 2021
    Report Date
    July 18, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EVENT DATE: 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. 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: ENDOSCOPIC PYLOROMYOTOMY IN MINIMALLY INVASIVE ESOPHAGECTOMY: A NOVEL APPROACH. AUTHORS: YEHONATAN NEVO, · ALEXANDER CALDERONE, ANITHA KAMMILI, CYRIL BOUIIIA, STEPHANE RENAUD, JONATHAN COOLS-LARTIGUE, JONATHAN SPICER, CARMEN MUELLER, LORENZO FERRI. CITATION CITE: SURGICAL ENDOSCOPY (2022) 36:2341-2348 HTTPS://DOI.ORG/10.1007/S00464-021-08511-0. THIS STUDY IS NOT DESIGNED TO STUDY IF PYLORIC DRAINAGE IS BETTER THAN NO-DRAINAGE, BUT RATHER ADDRESSES THE QUESTION IF A NOVEL, TECHNICALLY FACILE, ENDOSCOPIC TECHNIQUE CAN REPLACE A SURGICAL APPROACH IN PATIENTS UNDERGOING MIE IN WHOM A DRAINAGE PROCEDURE IS PLANNED. THIS IS A RETROSPECTIVE ANALYSIS OF A PROSPECTIVELY MAIN­ TAINED INSTITUTIONAL DATABASE OF ESOPHAGECTORNIES PERFORMED AT THE THORACIC SURGERY SERVICE IN MCGILL UNIVERSITY HEALTH CENTRE. ALL 94 PATIENTS UNDERGOING MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) FOR CANCER FROM JANUARY 2010 TO DECEMBER 2019 WERE IDENTIFIED. 3-0 PDS SUTURES, HARMONIC SCALPEL AND 3-0 VICRYL SUTURE WERE USED. REPOORTED COMPLICATIONS INCLUDED ANASTOMOTIC LEAKAGE (N=10), PULMONARY COMPLICATIONS (N=19) MORTALITY (N=2). IN CONCLUSION ENDOSCOPIC PYLOROMYOTOMY USING A NOVEL APPROACH IS A SAFE, QUICK AND REPRODUCIBLE TECHNIQUE WITH COMPARABLE RESULTS TO A SURGICAL PM IN THE SETTING OF MINIMALLY INVASIVE ESOPHAGECTOMY (MIE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960404 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention GENERATOR