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 Pleural Effusion (2010); Sepsis (2067); Ascites (2596); No Code Available (3191)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Title: thoracoscopic surgery for hepatocellular carcinoma located in the hepatic dome: technical aspect and oncological results source: asian journal of endoscopic surgery 2020;13:375¿381.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature study performed last january 2000 to january 2016, as reported in literature article describing the surgical techniques for a thoracoscopic approach to treat hepatocellular carcinoma in the hepatic dome.Thoracoscopic hepatic resection was performed under direct vision through a diaphragmatic incision.Thoracoscopic radiofrequency ablation (trfa) was performed either with transdiaphragmatic puncture for deeply located tumors or under direct vision through a diaphragmatic incision for subcapsular tumors.Total of 107 patients with hepatocellular carcinoma in the hepatic dome were treated: 5 patients underwent thoracoscopic hepatic resection (thr) and 102 patients underwent thoracoscopic radiofrequency ablation (trfa).Complications in the trfa (thoracoscopic radiofrequency ablation) group totaled 13: (6) refractory pleural effusion, (1) thoracic empyema, (1) refractory ascites, (1) pleuritis, (2) sepsis and (2) others.

• 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: 10426227
• MDR Text Key: 203856643
• Report Number: 1717344-2020-00895
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• 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: 08/03/2020
• 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
• Patient Age: 67 YR