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

Model Number	7210812
Medical Device Problem Codes	Protective Measures Problem (3015); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a hip arthroscopy, when the vulcan generator was turned on, a loud alarm noise appear and a voltage cal failure error was displayed.The procedure was completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus functional testing could not be performed.Visual inspection of the customer provided image shows a vulcan unit with voltage calibration failure displayed on the screen.There was a relationship found between the subject 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.The complaint was confirmed and the root cause is 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 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.B5: updated description h6: updated codes.
Event or Problem Description
It was reported that during a hip arthroscopy, when the vulcan generator was turned on, a loud alarm noise occurred and a voltage cal failure error was displayed.The procedure was completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was no 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.Visual inspection of the customer provided image shows a vulcan unit with voltage calibration failure displayed on the screen.Visual inspection observed no issues.Functional evaluation revealed no issues.The complaint was confirmed but the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Device movement and shipment could have changed the conditions that caused the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: 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: 11944591
• Report Number: 1643264-2021-02074
• Device Sequence Number: 19756129
• Product Code: GEI
• UDI-Device Identifier: 03596010519399
• UDI-Public: 03596010519399
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2021

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: 7210812
• Device Catalogue Number: 7210812
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/08/2021; 10/11/2021
• Initial Report FDA Received Date: 06/06/2021
• Supplement Report FDA Received Date: 07/30/2021; 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1