BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN CUSA EXCEL

    MDR report key: 7513079 · Received May 14, 2018

    Report

    Report Number
    3006697299-2018-00026
    Event Type
    Death
    Date Received
    May 14, 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. LINKED TO MFG. REPORT NUMBERS: 3006697299-2018-00025, 2523190-2018-00069, AND 2523190-2018-00070. HTTPS://DOI.ORG/10.1016/J.HPB.2017.10.006.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. DHR REVIEW WAS NOT DONE AS THE REQUIRED INFORMATION WAS NOT REPORTED. AN INVESTIGATION FOR CAUSE WAS UNABLE TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION, THE COMPLAINT WILL BE REOPENED AND THE EVALUATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    HPB (2018) PUBLISHED ¿FULLY LAPAROSCOPIC LEFT HEPATECTOMY-A TECHNICAL REFERENCE PROPOSED FOR STANDARD PRACTICE COMPARED TO THE OPEN APPROACH: A RETROSPECTIVE PROPENSITY SCORE MODEL¿ IN WHICH IT DISCUSSED THE SAFETY AND EFFECTIVENESS OF THE LAPAROSCOPIC LEFT HEMIHEPATECTOMY (LLH) TECHNIQUE DEVELOPED AT HENRI MONDOR HOSPITAL SINCE 1996. A SINGLE-SERIES, RETROSPECTIVE PAIR-MATCHED SAFETY/EFFICACY STUDY WAS PERFORMED, COMPARING (LLH) WITH OPEN LEFT HEMIHEPATECTOMY (OLH). THE ANALYSIS COVERED 17 LLH AND 51 OLH PERFORMED FROM 1996 TO 2014. FOR THE LLH, THREE COAGULATION DEVICES WERE UTILIZED: HARMONIC ACE (ULTRACISION, ETHICON ENDO-SURGERY), LIGASURE (COVIDIEN) AND A BIPOLAR FORCEPS (MICROFRANCE) AND ONE ULTRASONIC DISSECTOR (CUSA, INTEGRA). RESULTS: NO POST-OPERATIVE DEATH OCCURRED IN THE LLH GROUP WHILE THREE PATIENTS DIED IN THE OLH GROUP. CONCLUSION: THE TECHNIQUE IS RECOMMENDED AS A POSSIBLE TECHNICAL REFERENCE FOR STANDARD LLH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355428 UNKNOWN CUSA EXCEL ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death