The aquabeam handpiece was returned for investigation.During functional testing, the aquabeam handpiece functioned as intended.A review of the device history record (dhr) (b)(4)/serial number (b)(6) and aquabeam handpiece / lot number 23c00936 was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.Section 11.2.7 sterile motorpack draping and docking with the aquabeam handpiece contains the note to, "verify the motorpack is securely engaged to the aquabeam handpiece by attempting to pull the aquabeam handpiece off of the motorpack.The aquabeam handpiece should remain connected to the motorpack if properly engaged." the root cause of the reported event was unable to be determined as the aquabeam handpiece functioned as intended.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
|