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 Burn(s) (1757); Peritonitis (2252)

Event Date 03/15/2022

Event Type  Death  

Manufacturer Narrative

Title: comparison of the results of therapy for ct1 renal carcinoma with nephron-sparing surgery (nss) vs.Percutaneous thermal ablation (ta) source: journal of personalized medicine 2022, 12, 495.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study from 2014 to 2017 compared the outcomes of 140 patients with renal carcinoma treated with either nephron-sparing surgery or radio frequency thermal ablation using the cool tip rfa system.84 patients were treated with rfa with the following reported complications: one unspecified major complication (no other information provided in the article) and one death.The patient death was due to a thermal intestine injury followed by peritonitis.

• 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; 161 cheshire lane, suite 100, MN 55441 ; 7632104064
• MDR Report Key: 14274885
• MDR Text Key: 290642269
• Report Number: 1717344-2022-00538
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• 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): Other; Death
• Patient Age: 67 YR
• Patient Sex: Male