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

Model Number UNKNOWN RF ELECTRODE

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

Patient Problem Pleural Effusion (2010)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Title: primary tumour location is an important prognostic factor in colorectal cancer liver metastases following radiofrequency ablation source: https://doi.Org/10.1016/j.Crad.2020.07.014/ 0009-9260/ 2020 the royal college of radiologists.Published by elsevier ltd.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, this retrospective study compared the therapeutic efficacy of rfa treatments in patients with colonel cancer liver metastases based on the origins of the primary tumors.Between july 1, 2011 and june 20, 2018, 114 crclm patients with 177 lesions received rfa.The post procedural complications of the rectal cancer liver metastases (rclm) included: a pulmonary infection which was successfully treated with antibiotics and a pleural effusion which was treated with catheter drainage.The post procedural complications of the colon cancer liver metastases (cclm) group included three patients who developed pleural effusion which required aspiration.

• Brand Name: UNKNOWN RF 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: 12200105
• MDR Text Key: 262617826
• Report Number: 1717344-2021-01002
• 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: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN RF ELECTRODE
• Device Catalogue Number: UNKNOWN RF ELECTRODE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• 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