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

Model Number UNKNOWN COOL TIP ELECRTRODE

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

Patient Problems Perforation (2001); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Title: risk factors for the recurrence of early hepatocellular carcinoma treated by percutaneous radiofrequency ablation with a multiple-electrode switching system: a multicenter prospective study source: international journal of hyperthermia 2022, vol.39, no.1, 190¿199 accepted 24 december 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study of risk factors for the recurrence of early hepatocellular carcinoma treated by percutaneous radiofrequency ablation with a multiple-electrode switching system: a multicenter prospective study, from 2013 to 2020 analyzed outcomes of 139 patients with hepatocellular carcinoma who underwent multi-electrode switching system (mess) radiofrequency ablation (rfa) using the cool-tip ablation system.Reported complications included, gallbladder perforation requiring additional surgery to remove gallbladder (cholecystectomy).Risk factors for the recurrence of early hepatocellular carcinoma treated by percutaneous radiofrequency ablation with a multiple-electrode switching system: a multicenter prospective study, yunhua tan, xin wang, kuansheng ma, lin zhang, jing li, ping chen <(>&<)> ben zhang, 2022, international journal of hyperthermia.

• Brand Name: UNKNOWN COOL TIP ELECRTRODE
• 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: 14516987
• MDR Text Key: 293153846
• Report Number: 1717344-2022-00640
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN COOL TIP ELECRTRODE
• Device Catalogue Number: UNKNOWN COOL TIP ELECRTRODE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2022
• 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): Required Intervention