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

Model Number	RFG2
Medical Device Problem Codes	Break (1069); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a rfg2 generator for repair.It was alleged that smoke was observed at the back of the device and the device was immediately removed.It is reported that the power supply rf controller pca was damaged and must be changed.The device was cleaned and disinfected.There was no patient harm reported for this event.
Additional Manufacturer Narrative
Device evaluation summary: the power supply and rf controller pca were changed at service.The generator was able to pass functional and safety testing after the generator components was replaced.It was verified the generator passed electrical safety standard iec 62353 prior to release.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RADIOFREQUENCY GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6507811
• Report Number: 2183870-2017-00180
• Device Sequence Number: 1458247
• Product Code: GEI
• UDI-Device Identifier: 10884521140394
• UDI-Public: 10884521140394
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040638
• 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
• Report Date (Section B): 05/15/2017

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 Model Number: RFG2
• Device Catalogue Number: RFG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: Not provided; 05/15/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 06/12/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1