A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that post aquablation procedure, the patient was taken back to the operation room due to bleeding; however, no signs of arterial bleeding were observed, but there was "a lot of anterior oozing".It was not reported how the reported anterior oozing was addressed.The patient also received 3 units of blood.Multiple follow-up attempts have been made for additional information; however, to date, no additional information has been received.The patient has been discharged.No malfunction of the aquabeam robotic system was reported.
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The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The investigation of this event consisted of a review of the device history record (dhr) and labeling.A review of the device history record (dhr) for ab2000-b /serial number (b)(6) was performed, 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 device 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.8.32 sterile a.After the after the aquabeam handpiece removal, follow the standard clot handpiece removal, follow the standard clot evacuation procedure to remove clots and tissue with a cystoscopic evacuation procedure to remove clots and tissue with a cystoscopic sheath by using an ellik bladder evacuator or toomey syringe.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 device was not returned for investigation because it performed as intended during the aquablation procedure and was confirmed through our investigation of the event.The aquabeam robotic system's instructions for use lists bleeding as a potential risk of the aquablation procedure and provides adequate instructions on how to achieve appropriate hemostasis.Based on the review of the information provided plus the dhr and labeling, 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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