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

Model Number	7210812S3E
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the surgeon was performing a subacromial decompression using an electroblade and vulcan rf unit.Then he went to use the cautery feature and nothing happened.No error message.He checked the connections to the vulcan and all were plugged in correctly, he changed the electroblade and it did not cauterize as well.An error message appeared on the vulcan saying unable to determine voltage service required.There was no backup device available and no patient injury was reported.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: 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: 7355927
• Report Number: 1643264-2018-00240
• Device Sequence Number: 2023477
• Product Code: GEI
• UDI-Device Identifier: 00885554031225
• UDI-Public: (01)00885554031225
• Combination Product (Y/N): N
• PMA/510(K) Number: K991140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2018

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 Model Number: 7210812S3E
• Device Catalogue Number: 7210812S3E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1