|
Catalog Number 66800472 |
Device Problem
Defective Component (2292)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/10/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that, the wire of a footswitch, multi-function, versajet ii was found to be frayed at connection to versajet console.And when plugged into the versajet console it would not work.As this was noticed in a non-surgical environment, there was not any patient involved.
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).
|
|
Manufacturer Narrative
|
H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
|
|
Search Alerts/Recalls
|
|
|