Additional manufacturer narrative: adverse event problem: component code 4756: per the instructions for use, the aquabeam motorpack, a re-usable component of the aquabeam robotic system, provides power to the aquabeam handpiece by means of dc motors.Root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedure, the aquabeam motorpack stopped operating.It was observed that the motorpack cable began to fray at the cable strain relief.As a result, the aquablation procedure was aborted and rescheduled for a different date.There were no adverse health consequences to the patient due to the reported event.
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H.10 additional manufacturer narrative: the aquabeam motorpack was not returned for investigation of the reported event.Three (3) good faith efforts were made to retrieve the device without success.The current user manual, um0101-00 rev.F aquabeam robotic system user manual, states: 11.2.3 non-sterile: console, motorpack, and foot pedal connection connect the motorpack cable to the front of the console: connect the motorpack plug on the front right port.Ensure the connector locks in place and the red marks on the motorpack and the console align.11.2.7 sterile: motorpack draping and docking with the aquabeam handpiece dock the motorpack to the aquabeam handpiece: verify aquabeam handpiece nozzle position (i.E.The movement of the blue led) homes to the base of the aquabeam handpiece (fully proximal).O apply sterile tape over the connection between aquabeam handpiece and motorpack to seal it.O keep the motorpack and the aquabeam handpiece assembly with the scope clamp assembly in a secure and sterile environment.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam motorpack / lot number 20c00378 was performed, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system and its associated component met all design and manufacturing specifications when released for distribution.The root cause of the reported event was unable to be established as the device was not returned for investigation.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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