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

Catalog Number	RFG3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician used the rfg3 generator along with a closurefast catheter to treat the great saphenous vein as per ifu.The device was not reprocessed.It was reported that the vein did not close.On the follow up ultrasound, an ehit was present.It was reported that no thrombotic medication was prescribed.The patient is reported to be doing well.
Additional Manufacturer Narrative
Evaluation summary: the device was returned for evaluation.No procedure notes or photos of the reported issue were obtained.The generator was tested and found no issues that would appear to have contributed to the reported clinical event.The smart panel needed to be changed due to cosmetic damage.The generator functioned as intended during testing after 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; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7120426
• Report Number: 2183870-2017-00577
• Device Sequence Number: 13723138
• Product Code: GEI
• UDI-Device Identifier: 10884521196544
• UDI-Public: 10884521196544
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 02/22/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: RFG3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 02/22/2018
• 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