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 robotic system, lot number 19c01641, 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: 4. 3. Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bleeding. 8. 30. Sterile: after the aquabeam handpiece removal, follow the standard clot evacuation procedure to remove clots and tissue with a cystoscopic sheath by using an ellik bladder evacuator or toomey syringe. Use one of the following methods to achieve hemostasis: non-resective bladder neck cautery followed by foley balloon catheter insertion. The system was not returned for investigation of this event. 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.
Patient Sequence No: 1, Text Type: N, H10
A male patient underwent an aquablation procedure. Post-aquablation procedure, the patient was taken back to the operating room for debridement and cauterization to address bleeding (per manufacturer's instructions for use, bleeding is a potential risk of the aquablation procedure). Additional information was later received that the patient received a blood transfusion (number of units unknown) and was discharged in good condition two (2) days post-aquablation procedure. No malfunction of the aquabeam system was reported.
Patient Sequence No: 1, Text Type: D, B5