MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER COOL-TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ACT2020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pleural Effusion (2010)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Title assessment of radiofrequency ablation efficacy for hepatocellular carcinoma by histology and pretransplant radiology source liver transplantation, volume 25, 2019 (88-97) article number: 1 date of publication: 19 october 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature source of study performed january 2007 to december 2016, this study aimed at evaluating the histologic response after rfa of small hccs arising in cirrhosis.Data were reviewed from 78 patients with de novo early-stage hepatocellular carcinoma (hccs) who were treated with rfa and subsequently transplanted.Percutaneous rfa was performed using a cool-tip single needle (cool-tip radiofrequency electrode; radionics, minneapolis, usa) having a length of 20 cm with an exposed tip of 2 or 3 cm.The length of the exposed tip used depended on the tumor dimensions.The total number of rfa sessions was 92.During these sessions, 14 patients had some complications for a total of 18 (19.6%) events, but only 1 infectious complication graded as 3 (definable as major) occurred, returning a major complication rate of only 1.1%.Details are reported in table 4; grade 1-2 pleural effusion= 3.Notably, most of the complications were graded as minor, and morbidity in ablated patients having the largest tumor >3 cm was significantly higher (35.0%) than that of patients having the largest treated tumor =3 cm (9.7%; p = 0.01).No needle tract seeding among 125 treated nodules was detected.Authors noted that the data demonstrate the safety of the ablative procedure and are in keeping with the literature, and even in some instances, lower than the reported morbidity.Please refer to the attached full text for further details.

• Brand Name: COOL-TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8410363
• Report Number: 1717344-2019-00312
• Device Sequence Number: 11243476
• Product Code: GEI
• UDI-Device Identifier: 10884524001210
• UDI-Public: 10884524001210
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K973297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2019

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
• Operator of Device: Health Professional
• Device Model Number: ACT2020
• Device Catalogue Number: ACT2020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1