SMITH & NEPHEW, INC. VULCAN GENERATOR CE MARK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
|
Back to Search Results |
|
Model Number 7210812 |
Device Problem
Unexpected Shutdown (4019)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/11/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal complaint reference (b)(4).
|
|
Event Description
|
It was reported that the vulcan generator would shut off after so many seconds working with the wand, then it reboot.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.
|
|
Manufacturer Narrative
|
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.Rf generator failed for ¿rf disabled-check return electrode¿ error message and audible alarm.Cause of errors and alarm was a defective electronic component on the rf board.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.
|
|
Search Alerts/Recalls
|
|
|