H10: additional narrative/data.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 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 system met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use (ifu) - japan, ifu0107-00, rev.A was reviewed and states the following: 3.Contraindications: do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use.A root cause of the reported event could not be determined.The treating surgeon reported that this event was not related to aquabeam robotic system.Based on the event details plus a review of 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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On (b)(6) 2023, a male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that 5 days post aquablation therapy, the patient developed pneumonia and experienced cardiac arrest.The patient was resuscitated and is reported to have fully recovered.The event was reported as severe and serious.The treating surgeon reported that this event was not related to aquabeam robotic system.No malfunction of the aquabeam robotic system was reported.
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