BEUDAMED
    FDA Adverse Event Death Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 15462068 · Received September 21, 2022

    Report

    Report Number
    3005075853-2022-06294
    Event Type
    Death
    Date Received
    September 21, 2022
    Date of Event
    May 21, 2021
    Report Date
    September 21, 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
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF DEATH 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 DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. DOES THE AUTHOR/SURGEON BELIEVE THAT THERE WERE ANY ETHICON DEVICE DEFICIENCIES THAT CAUSED OR CONTRIBUTED TO THE NEGATIVE PATIENT OUTCOMES OR THE DEATH? WOULD THE AUTHOR/SURGEON BE INTERESTED IN SPEAKING WITH ETHICON MEDICAL AND ENGINEERING TEAM REGARDING THIS EVENT? 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: 10/19/2022. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES CAUSED OR CONTRIBUTED TO THE 4 DEATHS MENTIONED IN THE ARTICLE? 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: LAPAROSCOPIC PANCREATICODUODENECTOMY: A RETROSPECTIVE STUDY OF 200 CASES AND THE OPTIMIZATION OF THE SINGLE-CENTER LEARNING CURVE. AUTHORS: YI-CHEN TANG, QIN-QIN LIU, YONG-GANG HE, JING LI, XIAO-BING HUANG. CITATION CITE: TRANSL CANCER RES 2021;10(7):3436-3447. DOI: 10.21037/TCR-21-518. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE THE COMPLICATIONS RATE CURVE, POSSIBLE CAUSE IN LARGE COHORT STUDIES, AND DEVELOP A PROTOCOL TO PREVENT THE SEVERE POSTOPERATIVE COMPLICATIONS. BETWEEN JANUARY 2015 AND DECEMBER 2019, THE STUDY INCLUDED 213 AND 204 PATIENTS UNDERGOING OPD AND LPD, RESPECTIVELY. POSTOPERATIVE OUTCOMES, COMPLICATIONS, AND COMPLICATION RISK, ALONG WITH OPERATION TIME WERE ANALYZED, AND THE LEARNING CURVE WAS DETERMINED. THE 3-0 PROLENE (WB558 ETHICON) WAS USED FOR THE FULL-THICKNESS SUTURE OF THE PANCREAS AND OUTER MUCOSA OF THE JEJUNUM. THE 5-0 PDS II (W9073 ETHICON) WAS USED FOR THE INTERRUPTED SUTURE OF THE PANCREATIC DUCT AND JEJUNAL MUCOSA. (VI) RECONSTRUCTION OF HEPATICOJEJUNOSTOMY: THE 5-0 POLYDIOXANONE (VCP397H ETHICON) AND 5-0 PDS II WERE CHOSEN FOR HEPATICOJEJUNOSTOMY. GEN11 INTELLIGENT ENERGY SYSTEM (ETHICON) AND HARMONIC 1100 SHEARS (ETHICON) WERE USED FOR ENERGY SEALING AND DISSECTING. REPORTED COMPLICATIONS INCLUDED CLAVIEN DINDO GRADE III (N=382 ), PANCREATIC FISTULA (N=30 ), ANASTOMOTIC LEAKAGE (N=7 ), HEMORRHAGE (N=34 ), INTRAPERITONEAL INFECTION, (N= 40) , DELAYED GASTRIC EMPTYING (N=55 ) , INCISION INFECTION (N=20) , LUNG INFECTION (N=52) DEATH (N=4). IN CONCLUSION LPD IS SAFE AND EFFECTIVE FOR PATIENTS WITH PANCREATIC CANCER, AND HAS A LONG LEARNING CURVE AND IMPROVED POSTOPERATIVE COMPLICATIONS IN 50 CASES. THIS STUDY¿S RESULTS WILL HELP IN REDUCING THE COMPLICATION RATES OF THE FIRST 50 CONSECUTIVE CASES OF LPD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567777 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death