MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number UNKNOWN COOL TIP ELECRTRODE

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

Patient Problems Pleural Effusion (2010); No Code Available (3191)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title radiofrequency ablation of stage ia non-small cell lung cancer in medically inoperable patients: results from the american college of surgeons oncology group z4033 (alliance) trial.Source cancer, volume 121, 2015(1-23) article number: 19 date of publication: 1 october 2015.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature study performed last december 2006 to november 2010, in a study evaluated the two-year overall survival (os), adverse event rate, local control rate and impact on pulmonary function tests (pfts) in medically inoperable patients with stage ia nsclc (non-small cell lung cancer) undergoing ct-guided rfa (radiofrequency ablation) in a prospective multi-center trial.54 patients m:f=25:29, median age/range= 76/60-89 were enrolled from 16 us centers 51 patients were eligible (biopsy proven stage ia nsclc and deemed medically inoperable by board certified thoracic surgeon) for evaluation.Pfts were obtained within 60 days of rfa, 3 and 24 months after rfa.All patients were treated with a covidien cluster cool-tip electrode (covidien, (b)(4)) under ct-guidance according to the manufacturer¿s specifications.Out of 54 patients, 1 had pleural effusion requiring drainage and 1 pulmonary infection.

• Brand Name: UNKNOWN COOL TIP ELECRTRODE
• 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: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9786516
• MDR Text Key: 182199501
• Report Number: 1717344-2020-00240
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN COOL TIP ELECRTRODE
• Device Catalogue Number: UNKNOWN COOL TIP ELECRTRODE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR