MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC UNKNOWN RF ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number UNKNOWN RF ELECTRODE

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

Patient Problems Abscess (1690); Fever (1858); Pain (1994); Pleural Effusion (2010); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/04/2020

Event Type  Injury  

Manufacturer Narrative

Title: feasibility and outcomes of percutaneous radiofrequency ablation for intrahepatic recurrent hepatocellular carcinoma after liver transplantation: a single-center experience source: international journal of hyperthermia, 37:1, 1202-1209 published online: 26 oct 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study evaluated the feasibility, effectiveness, and treatment outcomes of patients undergoing percutaneous-ultrasound guided radio frequency ablation (rfa) in the treatment of intrahepatic recurrent hepatocellular carcinoma (r-hcc) following liver transplantation between april 2008 and december 2019.It is noted that rfa was accomplished with cooltip electrodes in this study.There were 37 patients with 61 intrahepatic r-hccs included in the study and complications included: symptomatic pleural effusion treated with percutaneous drainage and liver abscess requiring percutaneous drainage.Additional complications included severe pain, asymptomatic pleural effusion, fever and biloma, however, no additional interventions were noted.

• Brand Name: UNKNOWN RF ELECTRODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 12480865
• MDR Text Key: 274589972
• Report Number: 3004962788-2021-00079
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• 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: 08/31/2021
• 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): Other