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

Model Number	7210812S
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the vulcan generator did not recognize the return electrode.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10.H3, h6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Additional Manufacturer Narrative
H10: 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 visual inspection was performed on the product and no issue was observed.Complaint of return ground failure was confirmed.Rf generator failed for ¿rf disabled-check return electrode¿ error message and audible alarm.Cause of errors and alarm was a defective electronic component.The complaint investigation has concluded the cause of the failure to be a defective electronic component.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.

• Brand Name: SVCE REPL 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
• MDR Report Key: 10474199
• Report Number: 1643264-2020-01015
• Device Sequence Number: 11465446
• Product Code: GEI
• UDI-Device Identifier: 03596010542182
• UDI-Public: 03596010542182
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup
• Report Date (Section B): 11/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: 7210812S
• Device Catalogue Number: 7210812S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 09/21/2020; 11/04/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/25/2020; 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1