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

Model Number 7210812

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/11/2020

Event Type  Injury  

Event Description

It was reported that during surgery, the vulcan generator had an unspecified failure.There were no adverse consequences or delays in the case, the surgeon was planning to use the device for the electroblade shaver, but used a stryker rf wand on the shelf instead.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h2, h3, h6.The reported device, used 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 self test failure was confirmed.Rf generator failed self test on power up with the front panel locked up and alarm sounding.Cause of s.T.O.P.Failure was a defective electronic component on the cpu pcb.Unit passed functional testing after a known good cpu pcb was installed.The complaint was confirmed and the root cause has been determined 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.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.A review of risk management files found that the reported failure was documented appropriately.A review of the operations service manual found the following warnings and precautions, the fault tone sounds briefly during generator startup, and in the event of a warning or fault condition.The volume of the fault tone cannot be adjusted by the user.The generator enters the fault mode if a fault is detected at any time during the generator¿s operation.In the fault mode the following occurs: the fault indicator light illuminates, a fault tone sounds, an error code and text message appear in the message display the generator, rf energy cannot be delivered.To exit the fault mode, turn the generator off and then turn it on again.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.

Manufacturer Narrative

Additional information in event.

Event Description

It was reported that during surgery, the vulcan generator was making an alert noise upon turning on.Nothing was hooked up to the generator at the time, tech support was called and recommended turning the console off then back on, but it continued to make to alert noise every time it was turned on.There were no adverse consequences or delays in the case, the surgeon was planning to use the device for the electroblade shaver, but used a stryker rf wand on the shelf instead.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• 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: 10624524
• MDR Text Key: 209757079
• Report Number: 1643264-2020-01393
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210812
• Device Catalogue Number: 7210812
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/04/2020
• Supplement Dates Manufacturer Received: 10/15/2020; 10/15/2020
• Supplement Dates FDA Received: 10/26/2020; 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention