BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9505065 · Received December 20, 2019

    Report

    Report Number
    3005075853-2019-24590
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    January 1, 2016
    Report Date
    November 27, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2016. MEDICAL DEVICE: 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 : SHORT-TERM OUTCOMES AFTER TRANSANAL AND LAPAROSCOPIC TOTAL MESORECTAL EXCISION FOR RECTAL CANCER. AUTHOR : A. O. RASULOV, Z. Z. MAMEDLI, S. S. GORDEYEV, N. A. KOZLOV, H. E. DZHUMABAEV. CITATION: TECH COLOPROCTOL (2016) 20:227¿234 / DOI 10.1007/S10151-015-1421-3. THE PURPOSE OF THIS PROSPECTIVE STUDY WAS TO COMPARE THE SHORT-TERM OUTCOMES OF TRANSANAL AND LAPAROSCOPIC (LAP) TOTAL MESORECTAL EXCISION (TME). FROM OCT 2013 TO JAN 2015, A TOTAL OF 45 PATIENTS UNDERWENT TME. THE PATIENTS WERE NON-RANDOMLY ASSIGNED TO EITHER TOTAL TME [N=22, (N=11 MALE, N=11 FEMALE, MEDIAN AGE 56 YEARS (30-69 YEARS), MEDIAN BMI 26.0 KG/M2 (19.7-32.3 KG/M2))] OR LAPAROSCOPIC TME [N=23 (N=14 MALE, N=9 FEMALE, MEDIAN AGE 60 YEARS (15-78 YEARS) MEDIAN BMI 26.0 KG/M2 (18.3-37.2 KG/M2))]. IN LAPAROSCOPIC TME, THE INFERIOR MESENTERIC ARTERY WAS MOBILIZED USING AN ULTRACISION HARMONIC SCALPEL (HARMONIC SCALPEL, ULTRACISION, ETHICON ENDOSURGERY) AND LIGATED AT ITS ORIGIN. COMPLICATIONS INCLUDED POSTOPERATIVE ILEUS CLAVIEN¿DINDO GRADE I (N=1); AND POSTOPERATIVE ILEUS CLAVIEN¿DINDO GRADE II (N=1) WHICH REQUIRED ADMINISTRATION OF CHOLINESTERASE INHIBITORS. IN OUR STUDY TATME WAS NOT ASSOCIATED WITH INCREASED INTRA- OR POST-OPERATIVE COMPLICATIONS AND WAS PROVEN TO BE A SAFE AND FEASIBLE APPROACH TO RECTAL CANCER SURGERY. ADEQUATE LATERAL AND DISTAL RESECTIONS, AS WELL AS COMPARABLE TME QUALITY, MAKE IT A VIABLE ALTERNATIVE TO LAPAROSCOPIC RESECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298995 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention