Catalog Number AB2000 |
Device Problems
Display or Visual Feedback Problem (1184); Moisture Damage (1405)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/13/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
H.10 additional manufacturer narrative: h.6 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 in-process.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
|
|
Event Description
|
A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that, before inserting the aquabeam handpiece, the treating surgeon observed saline leakage from the rubber seal at the bottom of the aquabeam handpiece.When a second aquabeam handpiece was opened, an "e22 - motorpack error" message was generated by the aquabeam robotic system.Despite multiple troubleshooting attempts, the error persisted.It was reported that moisture or small water droplets were observed on the aquabeam motorpack connector.The aquabeam motorpack exhibited unusual movements until the release button on the aquabeam handpiece broke.As a result, a third aquabeam handpiece and a second aquabeam motorpack were used, which resolved the issue, and the aquablation procedure was completed successfully.The reported event caused a surgical delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.
|
|
Manufacturer Narrative
|
The aquabeam motorpack was returned for investigation.Visual inspection revealed fluid ingress on the aquabeam motorpack to aquabeam handpiece connection port.During functional testing, an e22 error was triggered and could not be cleared.The root cause is unable to be determined.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam motorpack / lot number 20c00237 was conducted, which confirmed 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 specificiations when released for distribution.The aquabeam robotic system user manual, um0101 rev.F, states the following: table 5: system detected errors and faults.E22 - motorpack error.Release foot pedal and click x.If error persists, reconnect handpiece to motorpack.If error continues, replace handpiece.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
|
|
Search Alerts/Recalls
|
|