BEUDAMED
    FDA Adverse Event Death Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 15041086 · Received July 18, 2022

    Report

    Report Number
    3005075853-2022-04640
    Event Type
    Death
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF DEATH IS UNKNOWN. DATE OF EVENT: PUBLICATION YEAR OF 2021. 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 HARMONIC DEVICE CAUSED OR CONTRIBUTED TO THE PATIENTS¿ COMPLICATIONS AND/OR MORTALITY 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: 12/7/2022. 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: 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 MAI­NTAINED INSTITUTIONAL DATABASE OF ESOPHAGECTOMIES 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 . REPORTED 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
    2896710 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death GENERATOR