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 Problem Pneumothorax (2012)

Event Date 09/23/2021

Event Type  Injury  

Event Description

According to the literature, a retrospective study analyzed outcomes of pediatric patients with congenital lung malformation who underwent thoracoscopic segmentectomy and lobectomy between january 2018 and march 2019.The device was used in segmentectomies to divide the vessels and dissect the lung parynchema.In lobectomies, the device was used to cut off the incomplete fissure.There were 19 infants in each group and complications included asymptomatic pneumothorax.Pneumothorax resolved with extended drain and patients were discharged one day after drain removal.Hospital stay was extended.Subcutaneous emphysema was not related to the device.

Manufacturer Narrative

Title: medium-term pulmonary function test after thoracoscopic lobectomy and segmentectomy for congenital lung malformation: a comparative study with normal control source: frontiers in pediatrics; october 2021; volume 9; article 755328; pp 1-6.If information is provided in the future, a supplemental report will be issued.

• 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: 14272742
• MDR Text Key: 290683490
• Report Number: 1717344-2022-00532
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2022

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
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/04/2022
• 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): Hospitalization; Required Intervention