A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that toward the end of the first pass treatment, the aquablation procedure was aborted due to a suspected pulmonary embolism based on the patient's heart rate and vital signs (per manufacturer's instructions for use, embolism is a perioperative risk of the aquablation procedure).It was confirmed at a later date that the patient was released from the intensive care unit with no neurological damage.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 treatment log files, the device history record (dhr), and labeling.The aquabeam robotic system's treatment logs file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the treatment logs indicated that the system functioned as designed.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: warnings: procedure: as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o embolism.A root cause for the reported event could not be determined.The aquabeam robotic system instructions for use embolism as a potential risk of the aquablation procedure.Based on the event details plus a review of the treatment log files, 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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