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

Model Number UNKNOWN SI ELECTRODE

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

Patient Problems Pneumothorax (2012); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

Title: methods for dissecting intersegmental planes in segmentectomy: a randomized controlled trial.Source: (ann thorac surg 2020;110:258-64) accepted for publication (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a prospective study compared the feasibility, safety, economic efficiency and outcomes of the use of stapler devices versus electrocautery for dividing segments in patients who underwent video or robot-assisted thoracic segmentectomy between (b)(6) 2017 and (b)(6) 2018.In the electrocautery group, the intersegmental plane was divided with a monopolar cautery hook set at 60w.There were 32 patients in this group.Postoperative complications in the electrocautery group included: air leakage (7 patients) and pneumothorax after chest tube withdrawal (3 patients).Air leaks were treated with extended drain.Patients with pneumothorax were readmitted and required chest tube reinsertion or expectorant treatment.Hospital stay was extended.

• Brand Name: UNKNOWN SI ELECTRODE
• 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: 14214656
• MDR Text Key: 290120281
• Report Number: 1717344-2022-00494
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SI ELECTRODE
• Device Catalogue Number: UNKNOWN SI ELECTRODE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• 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; Hospitalization
• Patient Age: 53 YR
• Patient Weight: 62 KG