BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUSA EXCEL

    MDR report key: 7509444 · Received May 11, 2018

    Report

    Report Number
    3006697299-2018-00022
    Event Type
    Injury
    Date Received
    May 11, 2018
    Report Date
    April 20, 2018
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    LFL
    PMA / PMN Number
    K141668
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4). HTTP://JOURNALS.SAGEPUB.COM/HOME/SRI. DOI: 10.1177/1553350617723269.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE APPLICABLE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE COMPLETED AS THE REQUIRED INFORMATION WAS NOT REPORTED. AN INVESTIGATION FOR CAUSE WAS UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    SURGICAL INNOVATION (2017) PUBLISHED ¿COMPARATIVE STUDY WITH PROPENSITY SCORE MATCHING ANALYSIS OF TWO DIFFERENT METHODS OF TRANSECTION DURING HEMI-RIGHT HEPATECTOMY : ULTRACISION HARMONIC SCALPEL VERSUS CAVITRON ULTRASONIC ASPIRATOR¿. THE AIM OF THE STUDY WAS TO COMPARE ULTRACISION HARMONIC SCALPEL (UHS) WITH CAVITRON ULTRASONIC SURGICAL ASPIRATOR (CUSA) AMONG PATIENT WHO UNDERWENT HEMI-RIGHT HEPATECTOMIES (RH) TO HOMOGENIZE TRANSECTION AREAS FROM (B)(6) 2012 TO (B)(6) 2015. TWENTY (24) PATIENTS WHO UNDERWENT THE UHS SURGERY APPROACH WERE MATCHED WITH 24 PATIENTS WHO UNDERWENT THE CUSA TRANSECTION PROCEDURE FOR RH USING PROPENSITY SCORE MATCHING. RESULTS: IN THE UHS GROUP, THERE WAS LESS ESTIMATED BLOOD LOSS (EBL) OF 300 ML VERSUS 500 ML AND LESS NEED FOR BLOOD TRANSFUSION (BT) WITH 6 VERSUS 8 INTRAOPERATIVE BT AS COMPARED TO THE CUSA GROUP. INTRAOPERATIVE INCIDENTS OF SEPTIC SHOCK AND DIAPHRAGMATIC TEAR WERE REPORTED IN THE CUSA GROUP. POSTOPERATIVE OUTCOMES FOR PATIENTS WHO UNDERWENT THE CUSA TRANSECTION PROCEDURE BEFORE PROPENSITY SCORE MATCHING (PSM) ANALYSIS WERE: THREE (3) PERIHEPATIC COLLECTION, ONE (1) BILIARY LEAKAGE, SEVEN (7) PLEURAL EFFUSION, AND FIVE (5) PNEUMONITIS. CONCLUSION: THE UHS IS A SAFE AND EFFECTIVE METHOD OF LIVER PARENCHYMA TRANSECTION (LPT) AS COMPARED TO THE USE OF THE CUSA SYSTEM. TOTAL OPERATIVE TIME IS STATISTICALLY DECREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350409 UNKNOWN CUSA EXCEL ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other