Visual testing has confirmed a poor visualization with the aquabeam scope as reported by the user, this is indicative of a fiber optic break due to repetitive use of the scope.The aquabeam robotic system user manual, um0101-00 rev.F, states: 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup verify the aquabeam scope visualization via the camera source port.Note: obtain a new aquabeam scope if proper visualization cannot be verified the aquabeam scope is a reusable component where the service life is largely determined by wear, reprocessing methods, and any damage during use or handling.The aquabeam scope is within serviceable life as long as it remains undamaged and functional according to the inspection criteria prior to use provided to the reprocessor per ifu0204-00, aquabeam scope reprocessing instructions, intl, rev.E.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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