Catalog Number AB2000 |
Device Problem
Visual Prompts will not Clear (2281)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Root cause of the reported event has not yet been established.Investigation by manufacturer is currently in-process.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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Event Description
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A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during treatment, the aquabeam robotic system generated an "e22 - motorpack error" message, which was unable to be cleared despite multiple troubleshooting steps taken in efforts to resolve the issue.A second aquabeam handpiece was used which resolved the issue and the aquablation procedure was successfully completed.The reported event caused a surgical delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.
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Manufacturer Narrative
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05-dec-2023 procept biorobotics received additional information that the surgical procedure delay was under 20 minutes.Based on this information, it is not considered to cause or contribute to a death or serious injury or other significant adverse device experiences required by regulation, but rather result in minor inconvenience.
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Search Alerts/Recalls
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