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

Model Number UNKNOWN LIGASURE INSTRUMENT

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

Patient Problem Fistula (1862)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

Title: robotic lobectomy in children with severe bronchiectasis: a worthwhile new technology source: journal of pediatric surgery accepted 4 november 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a study analyzed the outcomes of 18 pediatric patients who underwent pulmonary lobectomy for severe localized bronchiectasis via thoracoscopic (vats) versus robotic (rats) lobectomy between 2014 and 2019.In 11 vats patients, ligasure was used for dissection of the lung parenchyma, adhesions and vessels up to 7mm.Post-operative complications in the vats patients were: one patient with a parenchymal leakage that required percutaneous drainage, and conversion to open procedure due to bleeding.Other complications not related to the device were: one patient with bronchial fistula and conversion to open procedure due to dissection difficulty.Robotic lobectomy in children with severe bronchiectasis: a worthwhile new technology, marion duranda, layla muslehb, fabrizio vattac,d, giorgia orofino, stefania querciagrossa, myriam jugief, olivier bustarretf christophe delacourt, sabine sarnacki, thomas blancc, naziha khen-dunlopc, elsevier inc.2020.

• Brand Name: UNKNOWN LIGASURE INSTRUMENT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 11167023
• MDR Text Key: 226772393
• Report Number: 1717344-2021-00056
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LIGASURE INSTRUMENT
• Device Catalogue Number: UNKNOWN LIGASURE INSTRUMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention