|
Model Number 66800039 |
Device Problems
Connection Problem (2900); Noise, Audible (3273)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 03/10/2023 |
Event Type
Injury
|
Event Description
|
It was reported that, during an arthroscopy, the versajet ii console does not do its function, and makes a lot of noise when used with a 8-position connection, and according to the customer, it does not work with the 14-position connection.The procedure was cancelled.Patient was not injured as consequence of this problem.
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).
|
|
Manufacturer Narrative
|
Internal complaint reference number:(b)(4) section b5 was corrected.
|
|
Event Description
|
It was reported that, during a wound debridement treatment, the versajet ii console does not work: it makes a lot of noise when used with a 8 mm handpiece, and it does not work with the 14 mm.The procedure was cancelled.Patient was not injured as consequence of this problem.
|
|
Manufacturer Narrative
|
Section h10: the device was returned for evaluation.A visual and functional assessment was performed.No material nor functional failures was observed, the device passed all testing.A documentation review was performed.The manufacturing records and inspection processes for the reported batch contain no contributory factors, records confirm that this batch was manufactured, meeting the required specifications.All inspection and testing requirement was met prior to the release.Historical review details previous cases of this nature, which are considered isolated in scope and there are no open nor closed escalation actions related to this event type.The risk management files adequately captures both of the reported concerns, with no updates required.The probable cause remains unknown.Factors may include a defect with the actual handpiece used, but that component has not bee returned for evaluation to support this case.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed, therefore no corrective actions are deemed necessary.Internal complaint reference number: (b)(4).
|
|
Search Alerts/Recalls
|
|
|