MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) UNKNOWN CUSA EXCEL; ULTRASONIC SURGICAL PRODUCTS

Catalog Number XXX-CUSA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Liver Damage/Dysfunction (1954); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device is not 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.

Event Description

Frontiers in surgery(may2019) published "comparison of outcomes between open major hepatectomy using cusa and laparoscopic major hepatectomy using ¿lotus¿ liver blade.A propensity score matched analysis".Introduction: evolution in laparoscopic liver surgery during the past two decades is an indisputable fact.According to the second international consensus conference for laparoscopic liver resection held in morioka, japan in 2014 major resections are still regarded as innovative procedures in the exploration phase.On this basis, our study aims to explore the efficacy and safety of laparoscopic vs.Open major liver resection and therefore increase the existing evidence on major laparoscopic liver surgery.Methods: all consecutive patients who underwent major liver resection, open and laparoscopic from january 2016 to may 2018 were identified from our prospectively maintained database.Propensity score matching analysis was performed using r statistical tool in spss to isolate matched open and laparoscopic cases which were compared for intraoperative and postoperative short-term outcomes.Lotus ultrasonic energy device was used for parenchymal transection in laparoscopic cases vs.Cusa in open procedures.Results: propensity score matching analysis was performed on 82 consecutive patients (61 open and 21 laparoscopic major hepatectomies) resulting in 40 matched patients, 20 in each group.The mean total duration of surgery and duration of parenchymal transection were slightly longer in the laparoscopic group (p = 0.419, p = 0.348).There was no difference in the intraoperative and postoperative transfusion rates.Patients after laparoscopic surgery were discharged 2 days earlier on average (p = 0.310).No difference was observed in complication rates and mortality.Adverse event: there were no specific patient demographics provided ¿ minor complications (3), major complications (3), transfusion, post-surgery (2), and bile leaks (3).Conclusion: the data did not reveal inferiority of the laparoscopic major hepatectomy vs.The open approach in any parameter compared.The use of the lotus ultrasonic energy device appeared to be efficient and safe for parenchymal transection in the laparoscopic procedures.

Manufacturer Narrative

The complaint could not be verified as the product was not returned in order to verify the complaint.Based on the customer reported failure ¿complications in literature¿ it is not possible to determine a possible root cause for this complaint as it is as a result of a literature review.Additionally, manufacturing records could not be reviewed.Should the product be returned for analysis, the complaint will be reopened and evaluation will be completed.

• Brand Name: UNKNOWN CUSA EXCEL
• Type of Device: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• MDR Report Key: 10280093
• MDR Text Key: 206519100
• Report Number: 3006697299-2020-00044
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K141674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CUSA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1