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

Model Number	7210812F3E
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (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.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.A complaint history review concluded this was a repeat issue.Visual inspection of the returned device did not identify any complaint related issues.Functional evaluation revealed the unit presented a voltage calibration error.The complaint was confirmed and a root cause has been associated with a component failure.Factors, unrelated to the manufacturing and design of the device, which could have contributed to the reported event, include connecting a shorted or defective rf wand which could result in damage to the rf pcb.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that the vulcan generator did not function.No case involved.Results of investigation have concluded that this unit displayed a voltage calibration error 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: REFURBISHED 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: 11570753
• Report Number: 1643264-2021-01148
• Device Sequence Number: 11643182
• Product Code: GEI
• UDI-Device Identifier: 00885554031232
• UDI-Public: 00885554031232
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K991140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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 Model Number: 7210812F3E
• Device Catalogue Number: 7210812F3E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1