MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RFB VULCAN GENERATOR CE MARK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	7210812F
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the generator was overheating.It is unknown when was found the issue and if a backup device was available.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Event description updated.
Event or Problem Description
It was reported that during an unknown procedure, the generator was overheating.Backup device was available to complete the procedure.No delay and no patient injuries were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and a scratched lid was observed.Initial evaluation found no problems.An evaluation performed in service revealed there was an open circuit on the nem cable and the front harness assembly needed to be replaced.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: RFB VULCAN GENERATOR CE MARK
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 9447403
• Report Number: 1643264-2019-00871
• Device Sequence Number: 2158661
• Product Code: GEI
• UDI-Device Identifier: 03596010613561
• UDI-Public: 03596010613561
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K991140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2020

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: 7210812F
• Device Catalogue Number: 7210812F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 12/13/2019; 01/24/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 12/17/2019; 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1