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

Model Number UNKNOWN COOL TIP ELECTRODE

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

Patient Problems Hemorrhage/Bleeding (1888); Hemothorax (1896); Pneumothorax (2012)

Event Date 10/10/2021

Event Type  Injury  

Manufacturer Narrative

Title: comparison between surgery and thermal ablation for adrenal metastases: a retrospective study source: international journal of hyperthermia 2021, vol.38, no.1, 1541¿1547 published online: 02 nov 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature of comparison between surgery and thermal ablation for adrenal metastases: a retrospective study, a retrospective study from 2008 to 2018 analyzed outcomes of 133 patients with adrenal metastases who underwent either surgical resection or thermal ablation.A total of 57 patients underwent thermal ablation consisting of microwave and cryo ablation with competitor device and radiofrequency ablation with either the cool tip ablation system or competitor device.Minor complications related to thermal ablation included hemothorax, pneumothorax, and hemorrhage.

• Brand Name: UNKNOWN COOL TIP 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: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 14223233
• MDR Text Key: 290280006
• Report Number: 1717344-2022-00505
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN COOL TIP ELECTRODE
• Device Catalogue Number: UNKNOWN COOL TIP ELECTRODE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2022
• 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): Other