BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUSA EXCEL

    MDR report key: 7506876 · Received May 11, 2018

    Report

    Report Number
    3006697299-2018-00020
    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 · 0

    THE DEVICE HISTORY RECORD REVIEW (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE REQUIRED INFORMATION WAS NOT REPORTED. THE COMPLAINT IS UNCONFIRMED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. AN INVESTIGATION FOR CAUSE WAS UNABLE TO BE PERFORMED. IF THE PRODUCT IS RETURNED , THE COMPLAINT WILL BE REOPENED AND THE EVALUATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENTS 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). HTTPS://DOI.ORG/10.1089/LAP.2017.0326.

    Description of Event or Problem · 1

    JOURNAL OF LAPAROENDOSCOPIC AND ADVANCED SURGICAL TECHNIQUES (2017) PUBLISHED "LAPAROSCOPIC VERSUS OPEN LIVER RESECTION FOR LESIONS ADJACENT TO MAJOR VESSELS: A PROPENSITY SCORE MATCHED ANALYSIS" IN WHICH IT COMPARED THE OUTCOMES AFTER LAPAROSCOPIC LIVER RESECTION (LLR) AND OPEN LIVER RESECTION (OLR) OF LESIONS ADJACENT TO MAJOR VESSELS. A RETROSPECTIVE ANALYSIS OF PATIENTS WITH HEPATIC TUMORS CLOSE TO MAIN OR SECOND BRANCHES OF GLISSON¿S TREE, TO THE MAJOR HEPATIC VEIN, OR TO THE INFERIOR VENA CAVA WITHIN 1 CM BETWEEN JAN2015 AND JAN2017 WAS PERFORMED BASED ON THE PROPENSITY SCORE MATCHING (PSM) METHOD. PATIENTS WERE DIVIDED INTO LLR AND OLR GROUPS ACCORDING TO THE DIFFERENT SURGICAL PROCEDURE RECEIVED. A TOTAL OF 64 PATIENTS UNDERWENT LLR AND 86 PATIENTS HAD OLR. AFTER 1:1 PSM, WELL-MATCHED 40 PATIENTS IN EACH GROUP WERE OBTAINED. FOR LLR, THE SUPERFICIAL PARENCHYMA DISSECTION WAS DONE BY HARMONIC SCALPEL (ETHICON ENDO-SURGERY) WHEREAS DEEPER TISSUE WAS ACCOMPLISHED BY A COMBINATION OF HARMONIC SCALPEL, LAPAROSCOPIC CAVITRON ULTRASONIC SURGICAL ASPIRATOR (CUSA, INTEGRA), AND LIGASURE (VALLEYLAB, INC.). WHILE FOR OPEN PROCEDURE, A RIGHT SUBCOASTAL INCISION WAS PERFORMED WITH THE PATIENTS PLACED IN SUPINE POSITION AND THE SURGICAL STRATEGY WAS SIMILAR TO LLR WITH THE CLAMP CRUSHING AND CUSA AS THE MAIN METHODS FOR PARENCHYMAL DISSECTION. RESULTS: THE MEDIAN POSTOPERATIVE HOSPITAL STAY WAS SHORTER IN THE LLR GROUP. THE OVERALL COMPLICATION RATES IN TERMS OF LIVER FAILURE, POSTOPERATIVE HEMORRHAGE, ASCITES, PNEUMONIA, PLEURAL EFFUSION, AND WOUND INFECTION WERE COMPARABLE BETWEEN LLR AND OLR GROUPS (LLR: 3 LIVER FAILURE, 2 ASCITES, 4 PNEUMONIA, 1 WOUND INFECTION; OLR: 4 LIVER FAILURE, 1 HEMORRHAGE, 2 ASCITES, 6 PNEUMONIA, 1 PLEURAL EFFUSION, 1 WOUND INFECTION). MAJOR COMPLICATIONS WERE OBSERVED ONLY IN THE OLR GROUP AND INCLUDED 2 PATIENTS WITH REFRACTORY ASCITES TREATED BY ABDOMINAL PARACENTESIS AND 1 PATIENT SUFFERING FROM HEMORRHAGE RECEIVED RELAPAROTOMY TO STOP BLEEDING. CONCLUSION: THE STUDY SHOWED THAT LLR WAS ASSOCIATED WITH LESS BLOOD LOSS, SHORTER HOSPITAL STAY, LOWER SEVERITY OF POSTOPERATIVE COMPLICATIONS AND ONCOLOGICAL OUTCOMES COMPARABLE WITH THOSE OF OLR. LLR FOR TUMORS ADJACENT TO MAJOR VESSELS APPEARS TO BE FEASIBLE AND SAFE IN SELECTED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349643 UNKNOWN CUSA EXCEL ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R HARMONIC SCALPEL (ETHICON ENDO-SURGERY)| LIGASURE (VALLEYLAB, INC.)| HARMONIC SCALPEL (ETHICON ENDO-SURGERY)| LIGASURE (VALLEYLAB, INC.)