The aquabeam robotic system is a reusable device; therefore it is currently in the possession of the user facility.The investigation of this event consisted of a review of the treatment log files, device history record (dhr) and labeling.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: 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: o bladder or prostate capsule perforation.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.A review of the treatment log files revealed that the aquabeam robotic system high velocity waterjet could not have caused the perforation.The aquabeam robotic system's ifu lists bladder perforation as a potential risk of the aquablation procedure.Based on the review of the treatment log files, 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.
|