MAUDE Adverse Event Report: COVIDIEN GENERATOR RADIOFREQUENCY; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	RFG3
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician was attempting to use a rfg3 generator with a cf7-7-60 closurefast catheter to treat a venous insufficiency in the gsv.The touch screen of the device was not working and a sound was emitted from the device when the physician started a 20 second cycle.The physician unplugged and re-plugged in the machine but the error remained.Another rfg3 generator was used to complete the treatment.Issues with this generator were reported to have occured intermittently over a period if a week but in the last 3-4 days it is reported that device subsequently stopped functioning.Two cases of endothermal heat induced thrombosis (ehit) reported no patient information is available.
Additional Manufacturer Narrative
Evaluation summary: the rfg3 generator was returned.Functional testing was performed.Visual inspection of the device showed the panel was scratched <(>&<)> the device was freezing when the dongle was inserted.The catheter port and the smart panel were replaced.If information is provided in the future, a supplemental report will be issued.

• Brand Name: GENERATOR RADIOFREQUENCY
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• MDR Report Key: 7078441
• Report Number: 2183870-2017-00539
• Device Sequence Number: 13954371
• Product Code: GEI
• UDI-Device Identifier: 10884521196544
• UDI-Public: 10884521196544
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K141858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RFG3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other