BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 10573568 · Received September 23, 2020

    Report

    Report Number
    3005075853-2020-04840
    Event Type
    Injury
    Date Received
    September 23, 2020
    Report Date
    August 28, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/23/2020. 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. KINDLY CONFIRM THE EVENT THAT LED TO ONE PATIENT IN THE ABT GROUP TO UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AND STENTING OF THE COMMON BILE DUCT. DOES THE SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSE OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE EVENT DESCRIPTION? IF YES, PLEASE EXPLAIN WHY.

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2019. 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.

    Description of Event or Problem · 1

    TITLE: AUTOLOGOUS BLOOD TRANSFUSION AND PRINGLE MANEUVER IN LAPAROSCOPIC SEGMENTAL HEPATECTOMY FOR BENIGN HEPATIC NEOPLASMS: A RETROSPECTIVE STUDY AUTHOR(S): LI-HUA JIA, MD, XIAO-MING MA, MD, QIU-LIANG YAN, MD, XIANG-SONG WU, MD, YAN CHEN, MD, QING-HUANG YE, MD, ZHI-JIANG WANG, MD, MAN-MAN QIU, MD, AND JIN-HUI ZHU, MD, PHD CITATION: JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES VOLUME 29, NUMBER 12, 2019; DOI: 10.1089/LAP.2019.0407. THIS RETROSPECTIVE STUDY AIMED TO INVESTIGATE THE EFFECT OF AUTOLOGOUS BLOOD TRANSFUSION (ABT) AND PRINGLE MANEUVER (PM) ON POSTOPERATIVE EARLY LIVER FUNCTION AND SHORT-TERM POSTOPERATIVE RESULTS FOLLOWING LAPAROSCOPIC LIVER RESECTION IN PATIENTS WITH BENIGN HEPATIC NEOPLASMS. FROM JAN2015 TO MAY2018, 125 CONSECUTIVE PATIENTS WITH BENIGN HEPATIC NEOPLASM UNDERWENT LAPAROSCOPIC SEGMENTAL HEPATECTOMY USING EITHER OF THE TWO METHODS: ABT (N=68; MEAN SD AGE OF 46.5±6.3 YEARS; N=38 FEMALE AND N=30 MALE) OR PM (N=57; MEAN SD AGE OF 51.1±9.1 YEARS; N=31 FEMALE AND N=26 MALE). IN ALL PATIENTS, THE RESECTION LINE WAS MARKED USING AN ULTRASONIC DISSECTOR (HARMONIC SCALPEL; ETHICON ENDO-SURGERY, CINCINNATI, OH) OR A MONOPOLAR ELECTROSURGICAL DEVICE (PENG¿S MULTIFUNCTION OPERATIVE DISSECTOR).IN BOTH PROCEDURES, THE ULTRASONIC DISSECTOR AND THE MONOPOLAR ELECTROSURGICAL DEVICE AS OUR MAIN OPERATIVE INSTRUMENTS DURING PARENCHYMAL TRANSECTION. MINOR BLEEDING WAS ADDRESSED BY THE ULTRASONIC DISSECTOR OR THE MONOPOLAR ELECTROSURGICAL DEVICE; WE CONTROLLED INTRAOPERATIVE SEVERE HEMORRHAGE FROM MAJOR BLOOD VESSELS USING TITANIUM CLIPS, VASCULAR LOCKS, OR SUTURING USING PROLENE (ETHICON GMBH, HAMBURG, GERMANY) SUTURE. ONE PATIENT IN THE ABT GROUP UNDERWENT CONVERSION TO OPEN PROCEDURE SECONDARY TO UNCONTROLLABLE BLEEDING. POSTOPERATIVELY, COMPLICATIONS INCLUDED BLEEDING (N=6 ABT GROUP) TREATED WITH HEMOSTATICS; MAJOR BLEEDING (N=1 PM GROUP) TREATED WITH LAPAROSCOPIC HEMOSTASIS; FEVER (N=5 ABT GROUP AND N=4 PM GROUP) TREATED WITH ANTIBIOTICS ONLY; BILIARY FISTULA (N=2) WHICH WAS SUCCESSFULLY TREATED WITH DRAINAGE BY PLACING A PIGTAIL CATHETER PERCUTANEOUSLY; AND ONE PATIENT IN THE ABT GROUP UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AND STENTING OF THE COMMON BILE DUCT. COMPARED WITH PRINGLE¿S MANEUVER, LAPAROSCOPIC HEPATECTOMY WITH ABT PROMOTED EARLY RECOVERY OF LIVER FUNCTION AND REDUCED HOSPITALIZATION COSTS IN SELECT PATIENTS WITH BENIGN HEPATIC NEOPLASMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040394 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR AND HANDPIECE| GENERATOR AND HANDPIECE