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

Catalog Number	7210812S3E
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).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.Visual inspection observed the front bezel is damaged.A functional evaluation revealed the unit does not recognize the nem or return ground.The complaint was confirmed and a root cause has been associated with an electrical component failure.Factors, unrelated to the manufacturing and design of the device, which could have contributed to the reported event, include a defective rf pcb, a damaged nem cable or a nem circuit failure.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that the impedance in the vulcan generator was faulting.No case involved.Results of investigation have concluded that this unit does not recognize return ground which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: SERVICE REPLACEMENT VULCAN GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11498932
• Report Number: 1643264-2021-01052
• Device Sequence Number: 4497600
• Product Code: GEI
• UDI-Device Identifier: 00885554031225
• UDI-Public: 885554031225
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 03/16/2021

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: 7210812S3E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1