BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9525590 · Received December 27, 2019

    Report

    Report Number
    3005075853-2019-24773
    Event Type
    Injury
    Date Received
    December 27, 2019
    Report Date
    November 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2012. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: LAPAROSCOPIC APPENDECTOMIES: DOES TECHNIQUE MATTER? AUTHOR : HUFFORD T.J.; MARKART R.; SAXE J.M. AUTHORS: HUFFORD T.J.; MARKART R.; SAXE J.M. CITATION: SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES. CONFERENCE: 2012 SCIENTIFIC SESSION OF THE SOCIETY OF AMERICAN GASTROINTESTINAL AND ENDOSCOPIC SURGEONS, SAGES 2012. SAN DIEGO, CA UNITED STATES. CONFERENCE. PUBLICATION: (VAR.PAGINGS). 26 (SUPPL. 1) (PP S274), 2012. DATE OF PUBLICATION: MARCH 2012. THE OBJECTIVE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE DIFFERENCES IN BOTH OUTCOME AND COST IN THE TWO TECHNIQUES IN PERFORMING LAPAROSCOPIC APPENDECTOMY, FIRST METHOD UTILIZING ENDOSTAPLER AND ENDOCATCH BAG AND THE SECOND METHOD EMPLOYED THE HARMONIC SCALPEL AND AN ENDOLOOP. A TOTAL OF 114 PATIENTS (N = 81 FOR ENDOSTAPLER; N = 33 FOR ENDOLOOP) WHO UNDERWENT LAPAROSCOPIC APPENDECTOMY WERE INCLUDED IN THE RETROSPECTIVE CHART REVIEW FOR A PERIOD OF 6 MONTHS FROM JANUARY 2011 TO JULY 2011. THE TWO METHODS DID NOT DIFFER ON ABSCESS (ENDOLOOP = 12%, ENDOSTAPLER = 9%, P = .73) AND RETURN FOR COMPLICATIONS (12 VS. 17%, P = .49). THE AUTHORS CONCLUDED THAT ENDOLOOP AND ENDOSTAPLER METHODS DO NOT DIFFER IN CLINICAL OUTCOMES, BUT THE ENDOLOOP IS NOTABLY LESS COSTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317316 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1