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

Catalog Number	7210812F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy the generator was not working.No back up device was available, no delay nor patient injuries were reported.
Additional Manufacturer Narrative
There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of functional failure could not be reproduced.Unit passed functional testing during 6 hour burn in and power output was normal throughout testing.All functions perform as expected.All power and impedance readings were within spec.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• 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: 8586491
• Report Number: 1643264-2019-00319
• Device Sequence Number: 1836608
• Product Code: GEI
• UDI-Device Identifier: 03596010613561
• UDI-Public: 03596010613561
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: 7210812F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1