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

Model Number	7210812F
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the vulcan generator had a voltage cal failure error after it was on for a period of time.The procedure was completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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 no issue was observed.Complaint of voltage cal failure could not be reproduced.Rf generator passed all functional tests and 2 hour burn-in with no faults or errors.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.A complaint history review concluded this was a repeat issue.

• 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
• MDR Report Key: 10813942
• Report Number: 1643264-2020-01743
• Device Sequence Number: 4086691
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: 10/28/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1