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 Codes	Inflammation (1932); Ulcer (2274)
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 has been reported that a patient was treated with a closurefast catheter and rfg generator.The patient has shown inflammatory response in all ablation treated area and ulcers.
Additional Manufacturer Narrative
The rfg3 generator was not returned for evaluation.Four images were received for evaluation: image 1 showed redness on the treated leg, image 2 showed redness and swelling of the treated leg, image 3 showed redness and blistering of the patient treated, image 4 showed labelling of a rfg3 generator.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: the generator was received for evaluation.Attempts were made to retrieve the data from the sd card but it was discovered that it was defective and the data could not be read.Usd data from the generator was extracted and evaluated.It could be seen that the clf rf cycle finished with low temperature and some rf power (12 to 14 watts).It is possible that this indicates that the catheter may have moved while still in clf rf cycle.The power switch needed to be replaced due to cosmetic damages, and the catheter port needed to be replaced because residue was found inside the port.Update received - no further information available.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: device was returned on (b)(6) 2018.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; plymouth MN 55442
• MDR Report Key: 7494461
• Report Number: 2183870-2018-00262
• Device Sequence Number: 19161144
• Product Code: GEI
• UDI-Device Identifier: 10884521196544
• UDI-Public: 10884521196544
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K141858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/16/2018

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: 05/08/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 05/15/2018; 09/17/2018; 09/17/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/13/2018; 10/15/2018; 10/16/2018
• 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: Required Intervention