SMITH & NEPHEW, INC. VULCAN GENERATOR CE MARK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
|
Back to Search Results |
|
Model Number 7210812 |
Device Problem
Protective Measures Problem (3015)
|
Patient Problem
No Information (3190)
|
Event Date 09/11/2020 |
Event Type
Injury
|
Event Description
|
It was reported that during a shoulder scope, when using the vulcan generator for a bone cutter electroblade, when the generator was turned on, it had a fault.The surgeon used the bone cutter without the coagulation portion provided by the vulcan, and used a stryker rf wand for coagulation.There was no delay or patient injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
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 visual inspection was performed on the product and no issue was observed.Complaint of a fault condition could not be reproduced.Unit passed functional testing during 2 hour burn-in and power output was normal throughout testing.All functions perform as expected.All power and impedance readings were within spec.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.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 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 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.
|
|
Search Alerts/Recalls
|
|
|