Model Number AB2000 |
Device Problem
Visual Prompts will not Clear (2281)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/05/2023 |
Event Type
malfunction
|
Event Description
|
A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during the aquablation procedure, an "e22 - motorpack error" message was generated by the aquabeam robotic system.As a result, the aquabeam handpiece was replaced with a new handpiece unit, and the procedure was successfully completed.The reported event caused a surgical procedure delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
The aquabeam handpiece was not returned for investigation.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 22c04150 was conducted, which confirmed that there were two (2) non-conformances issued to this lot during the manufacturing process that could potentially be related to the reported event.The affected units within the lot were segregated and reworked to address the non-conformances.The handpiece passed final inspection prior to release for distribution.The current user manual um0104-00 rev.G, aquabeam robotic system user manual was reviewed.Table 5 system detected errors and faults e22 - motorpack error release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece.11.2.5 sterile: aquabeam handpiece and aquabeam scope setup · hold the distal end of the scope tube tip approximately 1 inch (2.54 cm) from the fully proximal position and continue advancing the aquabeam scope forward until it is properly engaged with the aquabeam handpiece and then rotate the proximal key alignment adapter so that the dimple on the proximal key alignment adapter is facing up.· an audible click should be heard when the aquabeam scope is securely engaged with the aquabeam handpiece.Note: do not use excessive force to advance the aquabeam scope.If resistance is felt,gently rotate the aquabeam scope clockwise and counterclockwise while simultaneously applying forward pressure.A root cause for the reported event could not be established as the handpiece 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.
|
|
Manufacturer Narrative
|
The aquabeam handpiece was returned for investigation.Functional testing was able to replicate the e22 error.The root cause of the reported error is undeterminable.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 22c04150 was conducted, which confirmed that there were two (2) non-conformances issued to this lot during the manufacturing process that could potentially be related to the reported event.The affected units within the lot were segregated and reworked to address the non-conformances.The handpiece passed final inspection prior to release for distribution.The current user manual (b)(4) rev.G, aquabeam robotic system user manual was reviewed.Table 5 system detected errors and faults e22 - motorpack error release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece.11.2.5 sterile: aquabeam handpiece and aquabeam scope setup · hold the distal end of the scope tube tip approximately 1 inch (2.54 cm) from the fully proximal position and continue advancing the aquabeam scope forward until it is properly engaged with the aquabeam handpiece and then rotate the proximal key alignment adapter so that the dimple on the proximal key alignment adapter is facing up.· an audible click should be heard when the aquabeam scope is securely engaged with the aquabeam handpiece.Note: do not use excessive force to advance the aquabeam scope.If resistance is felt,gently rotate the aquabeam scope clockwise and counterclockwise while simultaneously applying forward pressure.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
|
|
Search Alerts/Recalls
|