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

Model Number 7210812

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2020

Event Type  malfunction  

Event Description

It was reported that the vulcan generator had no power.No case reported; therefore, there was no patient involvement.

Manufacturer Narrative

The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.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.The device was evaluated in service where the visual inspection revealed a bent plate, broken bezel, and that the unit was missing all of the feet.A functional evaluation revealed the device alarms when the pedal is pressed with a check return electrode error message.The complaint was confirmed and the root cause was determined to be an electrical component failure.Factors, unrelated to the manufacturing and design of the device, which could have contributed to the reported event, include an out of calibration rf board.

• 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
• MDR Report Key: 10564877
• MDR Text Key: 207899411
• Report Number: 1643264-2020-01248
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 03596010519399
• UDI-Public: 03596010519399
• Combination Product (y/n): N
• PMA/PMN Number: K991140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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
• Device Operator: Health Professional
• Device Model Number: 7210812
• Device Catalogue Number: 7210812
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1