A review of the aquabeam robotics system's log file confirmed no malfunctions related to the reported event.The review of the log file indicated that the system functioned as designed.A review of the device history record (dhr) for the aquabeam robotics system, lot number 19c00548, was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system, which could relate to the reported event.The review indicated that the system met all required specifications when released for distribution.A review for similar complaints on the aquabeam robotics system, lot number 19c00548, confirmed that there are no other similar events of this nature reported on this system.The system was not returned for investigation of this event.A root cause for the reported event could not be determined.Based on the review of the log file, dhr, and ifu the event is considered not to be device related.Additionally, the treating physician confirmed that the reported event was unrelated to the aquablation procedure.
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