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 Pneumonia (2011); Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Title randomized clinical trial of hepatic resection versus radiofrequency ablation for early-stage hepatocellular carcinoma.Source br j surg, volume 104, 2017(1775-1784) article number: 13 date of online publication: 1 nov 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature study performed july 2002 to june 2007, in a randomized trial aimed to test the hypothesis that radiofrequency ablation (rfa) is superior to hepatic resection in terms of lower tumour recurrence rate and better long-term survival.Patients with early-stage hepatocellular carcinoma hcc (solitary tumour no larger than 5 cm; or no more than 3 tumours, each 3 cm or smaller) were randomized into hepatic resection and rfa groups.Rfa was performed using an internally cooled electrode.Out of 109 patients in the rfa group, 1 had pneumonia, 2 with peptic ulcer, 3 with unspecified post-operative complications and another had its wound infected.

• 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: 9799101
• MDR Text Key: 182630983
• Report Number: 1717344-2020-00255
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/06/2020
• 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 Age: 57 YR