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

Model Number 7210812S3E

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event 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.

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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7355927
• MDR Text Key: 103033454
• Report Number: 1643264-2018-00240
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885554031225
• UDI-Public: (01)00885554031225
• Combination Product (y/n): N
• PMA/PMN Number: K991140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 7210812S3E
• Device Catalogue Number: 7210812S3E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1