BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9461289 · Received December 12, 2019

    Report

    Report Number
    3005075853-2019-24235
    Event Type
    Injury
    Date Received
    December 12, 2019
    Report Date
    November 14, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. DATE OF EVENT: PUBLICATION YEAR FOR THE JOURNAL ARTICLE IS 2018. 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. IDENTIFYING COMPLAINTS IN ARTICLE CANNOT BE REASONABLY INVESTIGATED DUE TO NO CONTACT INFORMATION BEING AVAILABLE. THIS COMPLAINT HAS BEEN DOCUMENTED BASED ON THE INFORMATION AVAILABLE WITHIN THE ARTICLE; HOWEVER, DUE TO THERE BEING NO CONTACT INFORMATION FOR THE AUTHOR, ADDITIONAL EVENT DETAILS WILL NOT BE PURSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF A JOURNAL ARTICLE, TITLE: ROBOTIC DONOR HEPATECTOMY. AUTHOR(S): GI HONG CHOI. CITATION: LIVER CANCER 2018;7(SUPPL 1):1¿220; DOI 10.1159/000490877. THE STUDY DISCUSSED ABOUT ROBOTIC DONOR HEPATECTOMY. FROM MARCH 2016 TO JANUARY 2018, 29 PATIENTS (FEMALE=13; MEDIAN AGE=22 YEARS, AGE RANGE 17-50 YEARS; MEDIAN BMI= 21.7, BMI RANGE 18.6 ¿ 26.8) UNDERWENT ROBOTIC DONOR RIGHT HEPATECTOMY. DURING PARENCHYMAL TRANSECTION, HARMONIC SCALPEL (ETHICON) IS MOUNTED ON THE LEFT HAND AND FORCEPS ON THE RIGHT HAND. THESE TRACTION AND TRANSECTION METHOD FACILITATE PARENCHYMAL TRANSECTION WITH ROBOTIC INSTRUMENTS. REPORTED COMPLICATION INCLUDED INJURY TO THE LEFT BILE DUCT (N=1), WHICH WAS CONVERTED TO MINI-LAPAROTOMY AND ROUX-EN-Y HEPATICOJEJUNOSTOMY WAS PERFORMED; BILOMA (N=1). IN CONCLUSION, ROBOTIC LIVING DONOR RIGHT HEPATECTOMY IS FEASIBLE AND CAN BE SAFELY PERFORMED IN EXPERIENCED HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257753 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention