A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during the aquablation procedural set-up, the aquabeam scope was unable to provide clear visualization.The aquabeam scope was observed to be broken.As a result, a new scope was opened and the procedure was continued through successful completion.The reported event caused a surgical procedure delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.
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The aquabeam scope was returned for investigation.During functional testing, the aquabeam scope did not produce an image, indicating a fiber optic break.The root cause was unable to be determined.A review of the device history record (dhr) ab2000-b/serial number (b)(6) and aquabeam scope/lot number 72221/s0016 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 current user manual um0101-00 rev.F, aquabeam robotic system user manual was reviewed and states the following: 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup: verify the aquabeam scope visualization via the camera source port.Note: obtain a new aquabeam scope if proper visualization cannot be verified.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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