A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that following the aquablation procedure, the patient developed sepsis overnight.The cause of the sepsis is unknown.A pet scan was done to rule out if there was any rectal or bladder perforation that could have occurred during the aquablation procedure, and it confirmed that there was no presence of air or fluid.The patient received antibiotics and was reported to be doing well.It was also reported that prior to undergoing aquablation, the patient had been admitted to the hospital due to hematuria.The patient was discharged home four (4) days after the aquablation procedure.No malfunctions of the aquabeam robotic system were reported.
|
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 nonconformances, 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: - infection a root cause for the reported event could not be determined.The cause of the sepsis is unknown.A pet scan was done to rule out if there was any rectal or bladder perforation that could have occurred during the aquablation procedure, and it confirmed that there was no presence of air or fluid.The patient received antibiotics and was reported to be doing well.It was also reported that prior to undergoing aquablation, the patient had been admitted to the hospital due to hematuria.The patient was discharged home four (4) days after the aquablation procedure.The aquabeam robotic system's ifu lists infection as a potential risk of the aquablation procedure.Based on the 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.
|