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

Model Number UNKNOWN LIGASURE INSTRUMENT

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

Patient Problems Hemorrhage/Bleeding (1888); Paralysis (1997)

Event Date 09/06/2021

Event Type  Injury  

Manufacturer Narrative

Title: the role of video-assisted thoracoscopic surgery in pediatric oncology: single-center experience and review of the literature source: frontiers in pediatrics, october 2021, volume 9, article 721914.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study reviewed the role of video-assisted thorascopic surgery (vats) in the treatment of pediatric malignancies from 2007 to 2020.In small children, a 3-mm operative trocar technique with 5-mm optic was carried out to perform biopsies, whereas in ablative surgery, one 5-mm operative trocar was reserved for ligasure r or other vessel sealers.There were 43 procedures performed on 38 patients.Complications included: two intraoperative bleeding which required conversion to open surgery.One case had persistent right diaphragmatic paralysis, treated with laparoscopic diaphragmatic plication one year later, which required intensive care assistance.

• Brand Name: UNKNOWN LIGASURE INSTRUMENT
• Type of Device: 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: 14245205
• MDR Text Key: 290454114
• Report Number: 1717344-2022-00517
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• 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
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 04/28/2022
• 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
• Patient Age: 8 YR
• Patient Sex: Female