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

Model Number 7210812

Device Problem Device Alarm System (1012)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2020

Event Type  malfunction  

Event Description

It was reported that the vulcan generator was alarming constantly.It is unknown whether the event happened during surgery and if there was a patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

Internal complaint reference case-(b)(4).H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was no 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 constant alarming could not be reproduced.Product passed functional testing and 2 hour burn-in with no faults or errors.Alarm did not occur during functional testing.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.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.No containment or corrective actions are recommended at this time.

• 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: 10767252
• MDR Text Key: 214104617
• Report Number: 1643264-2020-01666
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2021

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
• Device Operator: Health Professional
• Device Model Number: 7210812
• Device Catalogue Number: 7210812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/31/2020
• Supplement Dates Manufacturer Received: 11/25/2020; 03/05/2021
• Supplement Dates FDA Received: 12/02/2020; 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1