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

Catalog Number	RFG3
Medical Device Problem Code	Failure to Shut Off (2939)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician used an rfg3 with a rfs stylet for the vein closure treatment of a perforator vein.It is reported the touch screen in this generator would not respond.When pressed, the generator would not stop treatment.The power button was pressed to power off the generator.Perforator vein successfully treated and closed.No additional treatment required.No patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Manufacturer provided the unit history report for this device.The generator passed functional testing and visual inspection prior to release from service.Device evaluation: smart panel was found to be unresponsive and had oil residue inside.The smart panel was replaced.Other components not relevant to the reported failure were also 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: 6843928
• Report Number: 2183870-2017-00376
• Device Sequence Number: 496734
• Product Code: GEI
• UDI-Device Identifier: 10884521196544
• UDI-Public: 10884521196544
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 01/11/2018

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 Catalogue Number: RFG3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 08/07/2017; 12/13/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 09/06/2017; 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 134