A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) was informed that during the patient's post-anesthesia care unit stay, there was red urine color indicating blood loss.Subsequently, the patient was returned to the operating room for management of bleeding using cautery.A blood transfusion was necessary (per the manufacturer's instructions for use, bleeding is a perioperative risk of the aquablation procedure).The patient was discharged home the following day without residual symptoms.There were no reported malfunctions of the aquabeam robotic system.
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Correction: b1 corrected to adverse event the aquabeam robotic system is a reusable device; therefore it is currently in the possession of the user facility.The investigation of this event consisted of a review of the device history record (dhr) and instructions for use (ifu).A review of the device history record (dhr) ab2000-b/serial number (b)(6) 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 aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 4.3 warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bleeding section 8.32 states the following: a.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.B.Use one of the following methods to achieve hemostasis: cautery followed by foley balloon catheter insertion.Under spinal anesthesia, insert a balloon catheter in the bladder with bladder neck traction then fill the bladder with sterile saline and maintain for approximately 30-60 minutes before starting cbi (continuous bladder irrigation) balloon catheter in bladder with bladder neck traction balloon catheter in prostatic fossa: inflate balloon with 5cc in the bladder under trus guidance retract balloon into prostatic fossa inflate balloon to 30-50% of initial prostate volume apply mild traction on the catheter to hold the balloon catheter in place balloon catheter in bladder, no traction c.Start cbi per hospital protocol.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The aquabeam robotic system's instructions for use lists bleeding as a potential risk of aquablation therapy and provides adequate instructions on how to achieve appropriate hemostasis.Based on the review of the information provided plus a review of the dhr and ifu, the event is considered not to be device-related.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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