BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUSA EXCEL

    MDR report key: 7701949 · Received July 19, 2018

    Report

    Report Number
    3006697299-2018-00040
    Event Type
    Injury
    Date Received
    July 19, 2018
    Report Date
    July 2, 2018
    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 · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4). LINKED TO MFG. REPORT NUMBER: 3006697299-2018-00041 HTTPS://DOI.ORG/10.1007/S00464-017-5725-2.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE CANNOT BE CONFIRMED. NO SERIAL NUMBER WAS IDENTIFIED, AS SUCH A DHR REVIEW COULD NOT BE PERFORMED. THE COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME BECAUSE THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    SURGICAL ENDOSCOPY (2018) PUBLISHED "OUTCOMES FOLLOWING LAPAROSCOPIC VERSUS OPEN MAJOR HEPATECTOMY FOR HEPATOCELLULAR CARCINOMA IN PATIENTS WITH CIRRHOSIS: A PROPENSITY SCORE-MATCHED ANALYSIS" WHICH ANALYZED THE PERIOPERATIVE AND ONCOLOGICAL OUTCOMES OF LAPAROSCOPIC MAJOR HEPATECTOMY (LMH) FOR HEPATOCELLULAR CARCINOMA (HCC) WITH CIRRHOSIS COMPARED WITH OPEN MAJOR HEPATECTOMY (OMH). A RETROSPECTIVE ANALYSIS OF PATIENTS WITH CIRRHOSIS WHO UNDERWENT MAJOR HEPATECTOMY FOR HCC BETWEEN JANUARY 2015 AND JANUARY 2017 WAS PERFORMED. PATIENT WERE DIVIDED INTO THE LMH GROUP AND THE OMH GROUP. SHORT TERM AND ONCOLOGICAL OUTCOMES WERE COMPARED BEFORE AND AFTER 1:1 PROPENSITY SCORE MATCHING (PSM). A TOTAL OF 336 HCC PATIENTS WHO RECEIVED MAJOR LIVER RESECTION BETWEEN JANUARY 2015 AND JANUARY 2017 WERE RETROSPECTIVELY ANALYZED. OF WHICH, 103 PATIENTS MEETING THE INCLUSION AND EXCLUSION CRITERIA WERE SELECTED FOR COMPARISON (233 PATIENTS WERE EXCLUDED). THERE WERE 36 (35.0%) PATIENTS IN THE LMH GROUP AND 67 (65.0%) PATIENTS IN THE OMH GROUP. PATIENTS SELECTED WERE MALE OR FEMALE PATIENTS AGED 18-75 YEARS. FOR LMH, THE SUPERFICIAL PARENCHYMA WAS DISSECTED BY HARMONIC SCALPEL (ETHICON ENDO-SURGERY) WHILE THE DEEPER TISSUE WAS DISSECTED BY LAPAROSCOPIC CAVITRON ULTRASONIC SURGICAL ASPIRATOR (CUSA) OR LIGASURE. FOR VESSELS C5 MM IN DIAMETER, HEM-OLOCK CLIPS OR TITANIUM CLIPS WERE USED TO ACHIEVE VASCULAR CONTROL. THE HEPATIC VEINS AND PORTAL PEDICLES WERE TRANSECTED BY A LAPAROSCOPIC LINEAR STAPLER. FOR OMH, CAVITRON ULTRASONIC SURGICAL ASPIRATOR OR CLAMP CRUSHING WAS USED AS THE MAIN METHODS FOR PARENCHYMA TRANSECTION. AFTER DISCHARGE, ALL PATIENTS WERE FOLLOWED EVERY 1-3 MONTHS DURING THE FIRST YEAR AND EVERY 3-6 MONTHS AFTERWARDS. RESULTS: INTRAOPERATIVE DATA AND POSTOPERATIVE OUTCOME BEFORE PROPENSITY SCORE MATCHING: LMH (N=36): 300ML BLOOD LOSS; TWO (2) BLOOD TRANSFUSION; ELEVEN (11) OVERALL COMPLICATIONS; ZERO (0) MAJOR COMPLICATIONS; TEN (10) LIVER SPECIFIC COMPLICATIONS; EIGHT (8) LIVER FAILURE; ONE (1) HEMORRHAGE; FOUR (4) ASCITES; ZERO (0) BILIARY LEAKAGE; TWO (2) GENERAL COMPLICATION; ONE (1) RESPIRATORY INFECTION; ONE (1) WOUND INFECTION; ONE (1) PLEURAL EFFUSION. OMH (N=67): 400ML BLOOD LOSS; THIRTEEN (13) BLOOD TRANSFUSION; THIRTY SIX (36) OVERALL COMPLICATIONS; TWELVE (12) MAJOR COMPLICATIONS; THIRTY SIX (36) LIVER SPECIFIC COMPLICATIONS; FOURTEEN (14) LIVER FAILURE; THREE (3) HEMORRHAGE; TWENTY FIVE (25) ASCITES; SIX (6) BILIARY LEAKAGE; THIRTEEN (13) GENERAL COMPLICATION; NINE (9) RESPIRATORY INFECTION; SIX (6) WOUND INFECTION; NINE (9) PLEURAL EFFUSION. CONCLUSION: LMH FOR HCC PATIENTS WITH LIVER CIRRHOSIS SHOWED COMPARABLE RESULTS IN TERMS OF POSTOPERATIVE MORBIDITY AND ONCOLOGICAL OUTCOMES COMPARED WITH TRADITIONAL OPEN PROCEDURE. LMH MAY SERVE AS A SAFE AND FEASIBLE ALTERNATIVE FOR SELECTED HCC PATIENTS WITH CIRRHOSIS.

    Description of Event or Problem · 1

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545004 UNKNOWN CUSA EXCEL ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1 HARMONIC SCALPEL| HEM-O-LOCK CLIPS| LAPAROSCOPIC LINEAR STAPLER| LIGASURE| TITANIUM CLIPS