MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	LF1537
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the literature, a retrospective study analyzed outcomes of patients who underwent laparoscopic liver resection between january 2015 and october 2017.There were 264 patients in the study and ligasure 1537 was used to transect vessels with diameter between 3 mm and 10 mm in 70 patients.Complications included postoperative hemorrhage which required reoperation.Extended icu stay was reported.Other complications that were not related to the device included: ascites, hydrothorax and wound suture.Does liver cirrhosis have an impact on the results of different hepatic inflow occlusion methods in laparoscopic liver resection? a propensity score analysis: xiang lan, 2018, © 2018 international hepato-pancreato-biliary association inc.Published by elsevier ltd.All rights reserved.
Additional Manufacturer Narrative
Title: does liver cirrhosis have an impact on the results of different hepatic inflow occlusion methods in laparoscopic liver resection? a propensity score analysis source: hpb 2019, 21, 531¿538 accepted: 16 september 2018.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14237735
• Report Number: 1717344-2022-00516
• Device Sequence Number: 4774107
• Product Code: GEI
• UDI-Device Identifier: 10884524002293
• UDI-Public: 10884524002293
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2012
• Device Model Number: LF1537
• Device Catalogue Number: LF1537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown