Catalog Number AB2000 |
Device Problems
Break (1069); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/13/2023 |
Event Type
malfunction
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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 the aquablation procedural setup, there was no connection between the aquabeam motorpack and the aquabeam console, and a crack was observed on the aquabeam motorpack.Three different aquabeam handpieces were used, but the issue persisted.As a result, the aquablation procedure was aborted and converted to transurethral resection of the prostate (turp) surgery.The patient is reported to be doing well.There were no adverse health consequences to the patient due to this event.
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Manufacturer Narrative
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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 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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Manufacturer Narrative
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The aquabeam motorpack was returned for investigation.Visual inspection of the returned device revealed that the upper and lower shells had collapsed into each other.Functional testing of the returned device confirmed the reported event.The root cause was determined to be an assembly issue, as reconnecting the motorpack circuit and reassembling the motorpack shells resolved the reported issue.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam motorpack / lot number 22c01855 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 um0104-00 rev.G, aquabeam robotic system user manual, intl, english was reviewed.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.Submission of this report does not constitue an admission that the manufacturer's product caused or contributed to the event.
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Search Alerts/Recalls
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