BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUSA EXCEL

    MDR report key: 8662449 · Received June 3, 2019

    Report

    Report Number
    3006697299-2019-00061
    Event Type
    Injury
    Date Received
    June 3, 2019
    Report Date
    May 7, 2019
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION; HENCE AN INVESTIGATION FOR CAUSE WAS UNABLE TO BE PERFORMED. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE REQUIRED INFORMATION WAS NOT REPORTED. THE COMPLAINT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE IS EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG. REPORT NUMBER: 3006697299-2019-00060.

    Description of Event or Problem · 1

    THIS IS 2 OF 2 REPORTS. IN THE LITERATURE ARTICLE ¿PURE LAPAROSCOPIC LIVING DONOR LEFT LATERAL SECTIONECTOMY IN PEDIATRIC TRANSPLANTATION: A PROPENSITY SCORE ANALYSIS ON 220 CONSECUTIVE PATIENTS¿ BY DIETER C. BROERING, YASSER ELSHEIKH, MOHAMMED SHAGRANI, FAISAL ABAALKHAIL, AND ROBERTO I. TROISI, PUBLISHED LIVER TRANSPLANTATION 24 1019-1030 2018 AASLD, IT WAS REPORTED THAT THERE WERE ADVERSE EVENTS AFTER USE OF THE CUSA DEVICE IN THE LAPAROSCOPIC LEFT LATERAL SECTIONECTOMY PROCEDURES FOR LIVING LIVER DONATION. PER THE ARTICLE: ¿LEFT LATERAL SECTIONECTOMY FOR DONOR HEPATECTOMY IS A WELL-ESTABLISHED ALTERNATIVE TO DECEASED DONOR PEDIATRIC LIVER TRANSPLANTATION. HOWEVER, VERY LITTLE IS AVAILABLE ON THE LAPAROSCOPIC APPROACH (LAPAROSCOPIC LEFT LATERAL SECTIONECTOMY [L-LL S]). WITH THE AIM TO ASSESS SAFETY, REPRODUCIBILITY UNDER PROCTORSHIP, AND OUTCOMES FOLLOWING LIVING DONOR LIVER TRANSPLANTATION IN CHILDREN, A COMPARATIVE SINGLE-CENTER SERIES USING PROPENSITY SCORE MATCHING (PSM) TO EVALUATE OPEN LEFT LATERAL SECTIONECTOMY (O-LL S) VERSUS L-LL S WAS CARRIED OUT IN A RELATIVELY SHORT TIME PERIOD IN A HIGH-VOLUME PEDIATRIC TRANSPLANT CENTER. A RETROSPECTIVE, OBSERVATIONAL, SINGLE CENTER, PSM STUDY WAS CONDUCTED ON 220 CONSECUTIVE LIVING DONOR HEPATECTOMIES FROM JANUARY 2011 TO APRIL 2017. THE VARIABLES CONSIDERED FOR PSM WERE AS FOLLOWS: YEAR OF OPERATION, RECIPIENT AGE, INDICATION FOR TRANSPLANT, RECIPIENT WEIGHT, DONOR SEX, DONOR AGE, AND DONOR BODY MASS INDEX. AFTER MATCHING, 72 O-LL SS WERE FIT TO BE COMPARED WITH 72 L-LL SS. OPERATIVE TIME AND WARM ISCHEMIA TIME WERE SIGNIFICANTLY LONGER IN L-LL SS, WHEREAS BLOOD LOSS AND OVERALL DONOR COMPLICATION RATES WERE SIGNIFICANTLY LOWER. POSTOPERATIVE DAY 1 AND 4 PAIN SCORES WERE SIGNIFICANTLY LESS IN THE L-LL S GROUP (P = 0.015 AND 0.003, RESPECTIVELY). THE LENGTH OF HOSPITAL STAY WAS SIGNIFICANTLY SHORTER IN L-LL S (4.6 VERSUS 4.1 DAYS; P = 0.014). OVERALL DONOR BILIARY COMPLICATIONS WERE 9 (12.5%) AND 1 (1.4%) FOR O-LL S AND L-LL S (P = 0.022), RESPECTIVELY. VASCULAR COMPLICATIONS OCCURRED IN 3 (4.2%) CHILDREN WITHOUT GRAFT LOSS IN THE LAPAROSCOPIC GROUP. THE 1-, 3-, AND 5-YEAR OVERALL PATIENT SURVIVAL RATES WERE 98.5%, 90.9%, AND 90.9% IN THE O-LL S GROUP AND IN THE L-LL S GROUP 94.3%, 92.7%, AND 86.8% (P = 0.28). IN CONCLUSION, L-LL S FOR DONOR HEPATECTOMY IS A SAFE AND REPRODUCIBLE TECHNIQUE YIELDING BETTER DONOR PERIOPERATIVE OUTCOMES WITH RESPECT TO THE CONVENTIONAL APPROACH WITH SIMILAR RECIPIENT OUTCOMES.¿ AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE. FOR THE L-LLS GROUP, THE EVENTS ARE AS FOLLOWS: FEVER: 1, BILE LEAK: 1, PANCREATITIS: 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455711 UNKNOWN CUSA EXCEL ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1