H.10 additional manufacturer narrative: the aquabeam robotic system was not returned for investigation of this event and is currently in use at the user facility.The investigation consisted of a review of the information reported to procept, plus a review of the device history record (dhr) and labeling.A review of the device history record (dhr) ab2000-b rev.G/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's instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 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 for the reported event could not be determined.The information received through the treating surgeon confirmed that the reported hypotension was unrelated to the aquablation procedure.The patient presented with a long history of comorbidities.Based on the event details 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.
|