BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 15705182 · Received October 31, 2022

    Report

    Report Number
    1717344-2022-01344
    Event Type
    Injury
    Date Received
    October 31, 2022
    Date of Event
    April 22, 2021
    Report Date
    October 31, 2022
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: THIRD-GENERATION THREE-DIMENSIONAL DISPLAY SYSTEM FOR LAPAROSCOPIC RADICAL NEPHRECTOMY REDUCED SURGICAL COMPLICATIONS COMPARED TO A TWO DIMENSIONAL DISPLAY SYSTEM SOURCE: JOURNAL OF CLINICAL UROLOGY 2022, VOL. 15(5) 397¿403 © BRITISH ASSOCIATION OF UROLOGICAL SURGEONS 2021, ARTICLE REUSE GUIDELINES: SA GEPUB.COM/JOURNALS-PERMISSIONS, DOI: 10.1177/20514158211017414, JOURNALS.SAGEPUB.COM/HOME/URO. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN OCTOBER 2014 AND NOVEMBER 2017,A PROSPECTIVE STUDY COMPARED THE RESULTS OF PATIENTS WHO UNDERWENT LAPAROSCOPIC RADICAL NEPHRECTOMY(LRN) FOR CANCER USING 2D AND 3G 3D SYSTEMS. THIS PROSPECTIVE STUDY INCLUDED 35 PATIENTS DIAGNOSED WITH KIDNEY OR UPPER URINARY TRACT CANCER WHO WERE SCHEDULED FOR LRN. A SINGLE EXPERIENCED SURGEON PERFORMED 3G 3D LRN FOR 19 PATIENTS AND 16 PATIENTS IN THE 2D GROUP. LIGASURE MARYLAND WAS USED AS AN ENERGY DEVICE. 3D GROUP HAD 20% MAJOR COMPLICATIONS WHILE 2D GROUP HAD 37%; RENAL AND LUMBAR VEIN INJURIES OCCURRED IN 3D-LRN. PERITONEUM INJURY WAS FREQUENT IN 2D-LRN, THE PERITONEUM INJURIES WITH THE 2D SYSTEM ALL OCCURRED DURING THE PERIRENAL DISSECTION MANIPULATION AND WERE CAUSED BY THE OPERATOR MISINTERPRETING THE DEPTH OF THE STRIPPING LAYER AT THE TIME OF THE MANIPULATION TO DISSECT GEROTA¿S FASCIA FROM THE PERITONEUM. RENAL VEIN AND ADRENAL INJURIES OCCURRED IN 2D-LRN. AN ADRENAL INJURY OCCURRED DUE TO BEING CUT BY A VESSEL SEALING DEVICE, THERE WAS NO BLEEDING WAS OBSERVED. 3D GROUP HAD AN 80% MINOR COMPLICATIONS WHILE 2D GROUP HAD 63%; MOST OF THE OTHER COMPLICATIONS WERE VEIN INJURIES (WITH BLOOD LOSS OF 72ML TO 107.6ML), WHICH WERE MINIMAL AND CONTROLLED BY PRESSURE HEMOSTASIS AND ELECTROCOAGULATION HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482900 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other