BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9667442 · Received February 4, 2020

    Report

    Report Number
    3005075853-2020-00755
    Event Type
    Injury
    Date Received
    February 4, 2020
    Report Date
    January 6, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    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 2012. 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: THE ARTICLE PRESENTS THE EXPERIENCE OF 1115 LAPAROSCOPIC APPENDECTOMY. AUTHOR/S: MOSIN S.V. CITATION: SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES. CONFERENCE: 19TH INTERNATIONAL CONGRESS OF THE EUROPEAN ASSOCIATION FOR ENDOSCOPIC SURGERY, EAES 2011. TORINO ITALY. CONFERENCE PUBLICATION: (VAR.PAGINGS). 26 (SUPPL. 1) (PP S19), 2012; DOI: HTTP://DX.DOI.ORG/10.1007/S00464-014-3484-Z. THIS STUDY DISCUSSED ABOUT LAPAROSCOPIC APPENDECTOMY (LAE) TO 1115 PATIENTS PERFORMED FROM 2005 TO 2010, FOR SUSPECTED ACUTE APPENDICITIS. MONOPOLAR COAGULATION, LIGASURE AND HARMONIC SCALPEL (ETHICON) (N=153) WERE USED IN THE LAPAROSCOPIC APPENDECTOMY. REPORTED COMPLICATIONS INCLUDED APPENDICULAR ABSCESS (N=?); AND INTRA-ABDOMINAL COMPLICATIONS (N=?). IN CONCLUSION, LAE SHOULD BE THE PRIMARY METHOD OF TREATMENT OF ACUTE APPENDICITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130647 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other