A review of the system's log file was conducted, which confirmed that there were no malfunctions observed during the procedure, which could be related to the reported event.The system functioned as designed.A review of the device history record (dhr) serial number (b)(4) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications upon release for distribution.A review for similar events was conducted on the aquabeam system, serial number (b)(4), which confirmed that there were no other similar events reported on this system.The aquabeam robotic system's instructions for use (ifu), ifu0101, rev.C, states the following: do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use.In addition, do not use the system in the following: unable to safely stop anticoagulants or antiplatelet agents perioperatively.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bleeding.The system was not returned for investigation of this event.Per the ifu, patients must be able to safely stop anticoagulant agents before surgery.In addition, bleeding is a potential risk of the aquablation procedure.Based on the review of the log file, dhr, and ifu, the event is considered not to be device related.
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A male patient underwent an aquablation procedure.Post-aquablation procedure, the patient was taken back to the operating room to receive a transfusion of six (6) units of packed red cells (prbcs).The patient had a medical history of being on eliquis anticoagulant medication, which was stopped two (2) days prior to the aquablation procedure (per the manufacturer's instructions for use, patients must be able to safely stop anticoagulant agents before surgery).The patient was reported to be in good condition with no further clinical sequela.No malfunction of the aquabeam robotic system was reported.
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