BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9440368 · Received December 9, 2019

    Report

    Report Number
    3005075853-2019-24115
    Event Type
    Injury
    Date Received
    December 9, 2019
    Report Date
    November 11, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/9/2019. DATE OF EVENT: PUBLICATION YEAR OF 2007. 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: ROBOTIC-ASSISTED TOTAL MESORECTAL EXCISION (TME) FOR RECTAL CANCER RESULTS IN A SIGNIFICANTLY HIGHER QUALITY OF TME SPECIMEN COMPARED TO THE LAPAROSCOPIC APPROACH¿REPORT OF A SINGLE-CENTER EXPERIENCE. AUTHOR: HEIKO ASELMANN1 & JAN-NICLAS KERSEBAUM1 & ALEXANDER BERNSMEIER1 & JAN HENRIK BECKMANN1 & THORBEN MÖLLER, JAN HENDRIK EGBERTS1 & CLEMENS SCHAFMAYER1 & CHRISTOPH RÖCKEN2 & THOMAS BECKER1. CITATION: INTERNATIONAL JOURNAL OF COLORECTAL DISEASE (2018) 33:1575¿1581; DOI: HTTPS://DOI.ORG/10.1007/S00384-018-3111-X. THIS RETROSPECTIVE ANALYSIS OF PROSPECTIVE COLLECTED DATA AIMED TO ANALYZE SHORT-TERM OUTCOMES OF LAPAROSCOPIC AND ROBOTIC ANTERIOR RECTAL RESECTION FOR RECTAL CANCER. FROM 2011 TO 2016, 85 PATIENTS UNDERWENT MINIMALLY INVASIVE LOW ANTERIOR RECTAL RESECTIONS WITH TOTAL MESORECTAL EXCISION (TME) AND ANASTOMOSIS. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: ROBOTIC TME (N=44; N=59.1% MALE; MEAN AGE OF 61.1±11.54 YEARS) AND LAPAROSCOPIC TME (N=41; N=58.5 YEARS; MEAN AGE OF 65.1±12.0 YEARS). IN LAPAROSCOPIC TME, DISSECTION WAS CARRIED OUT USING HARMONIC ACE (ETHICON). ONE PATIENT IN LAPAROSCOPIC TME HAD BLEEDING FROM THE SPLENIC VEIN REQUIRING CONVERSION TO OPEN SURGERY. THIS CASE CONTROLLED-RETROSPECTIVE ANALYSIS SHOWS THAT ROBOTIC SURGERY IN RECTAL CANCER WAS ASSOCIATED WITH IMPROVED QUALITY OF THE TME SPECIMEN COMPARED TO LAPAROSCOPIC RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230073 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1