A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the jet alignment phase, the aquabeam foot pedal stopped operating.It was observed that the foot pedal cable was damaged.As a result, the aquablation procedure was aborted.There were no adverse health consequences to the patient due to the reported event.
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The aquabeam foot pedal was returned for investigation.Visual inspection of the returned aquabeam foot pedal confirmed the reported event as the connecting cable was observed to be detached from the aquabeam foot pedal.The root cause is undeterminable as it is unknown how the cord became detached from the aquabeam foot pedal, however, it is likely due to excessive force and tension being applied over time.A review of the device history record (dhr) ab2000-b/ serial number (b)(6) and the aquabeam foot pedal / lot number 22c02036 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, us, english was reviewed.4.1 warnings: general.To minimize the risk of transmitting disease from one patient to another, the console, cpu, foot pedal, power cord (on the roll stand), handpiece articulating arm, trus articulating arm, motorpack, and roll stand must be properly cleaned after each procedure.Failure to properly clean after each procedure may compromise patient safety.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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