BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9653595 · Received January 31, 2020

    Report

    Report Number
    3005075853-2020-00661
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    January 3, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2005. 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.

    Description of Event or Problem · 1

    TITLE: LAPAROSCOPIC PARTIAL NEPHRECTOMY IN RENAL CELL CANCER - RESULTS AND REPRODUCIBILITY BY DIFFERENT SURGEONS IN A HIGH VOLUME LAPAROSCOPIC CENTER AUTHOR: ANDREAS H. WILLE *, MAXIMILIAN TU¨ LLMANN, JAN ROIGAS, STEFAN A. LOENING, SERDAR DEGER. CITATION: EUROPEAN UROLOGY (2006); 49: 337¿343. DOI:10.1016/J.EURURO.2005.11.016. THE AUTHORS REPORTED THEIR TECHNIQUES, PERIOPERATIVE DATA AND ONCOLOGICAL OUTCOME IN A SINGLE CENTER EXPERIENCE WITH THREE DIFFERENT SURGEONS. BETWEEN MARCH 2001 AND OCTOBER 2004, 44 PATIENTS (36 MALE AND 8 FEMALE; MEAN AGE: 61 YEARS; AGE RANGE: 33 TO 79 YEARS) UNDERWENT LAPAROSCOPIC PARTIAL NEPHRECTOMY FOR EXOPHYTIC RENAL LESIONS. DURING THE PROCEDURE, TUMOR RESECTION WAS PERFORMED WITH SCISSORS OR THE HARMONIC SCALPEL (ETHICON). REPORTED COMPLICATION INCLUDED INFECTED HEMATOMA (N-?) IN WHICH THE PATIENT HAD AN OPEN REVISION AND THE NEED OF DRAINAGE AND RECEIVED TRANSFUSION, AND LYMPHORRHAGE (N-?) WHICH LED TO PROLONGED DRAINAGE TIME. LAPAROSCOPIC PARTIAL NEPHRECTOMY USING FLOSEAL IS A FEASIBLE AND SAFE METHOD FOR TREATMENT OF SMALL RENAL MASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113876 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention