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

Model Number	RFG3
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	Burn(s) (1757); Patient Problem/Medical Problem (2688)
Date of Event	06/12/2017
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
The physician intended to use the rfg3 to successfully treat the great saphenous vein as per ifu.It was reported the rfg3 acoustic signal of the generator and the seconds' indicator are not synchronized.Also the connection of the catheter into the generator does not work smoothly.The physician stated that he does not know if this has led to a wrong delivery of energy, and therefore if this might have caused the skin burn to the patient.The patient complained of itching at the access site.Three weeks post procedure the patient presented with a skin burn with necrosis to the groin area.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The reported clinical event has been confirmed from the picture provided; however the report of connection difficulties was not confirmed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received: it was reported that patient received 7 cycles of radiofrequency ablation on the right leg and 2 cycles on the left leg.The first segment of both legs were treated twice.The skin irritation was treated with "ialugen", antibiotic "augmentin" for 7 days, and "nsar".Patient's current system was reported to be good, with necrosis disappearing slowly and no systemic infection present.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: 6704577
• Report Number: 2183870-2017-00296
• Device Sequence Number: 670097
• Product Code: GEI
• UDI-Device Identifier: 10884521196544
• UDI-Public: 10884521196544
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 08/14/2017

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 Model Number: RFG3
• Device Catalogue Number: RFG3
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/21/2017
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 06/12/2017; 06/12/2017; 08/14/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 07/12/2017; 08/11/2017; 09/12/2017
• 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
• Patient Age: 36 YR
• Patient Weight: 54