MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABEAM ROBOTIC SYSTEM; FLUID JET REMOVAL SYSTEM

Catalog Number AB2000

Device Problems Visual Prompts will not Clear (2281); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

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.

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, following insertion of the aquabeam handpiece into the patient, the aquabeam scope experienced resistance and was unable to be advanced or retracted.During jet alignment with a second aquabeam handpiece, an "e22 - motorpack error" was generated by the aquabeam robotic system.Multiple troubleshooting steps were performed which resolved the error; however, upon reconnecting the aquabeam handpiece with the aquabeam motorpack, an unspecified error was generated by the aquabeam robotic system.A third aquabeam handpiece was used which resolved the issue and the procedure was able to be 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.

Manufacturer Narrative

The aquabeam handpiece was returned for investigation of the reported event.During functional testing, the aquabeam handpiece functioned as intended.The root cause of the reported issue could not be determined as the aquabeam handpiece functioned as intended.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam handpiece / lot number 23c04637 was performed, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufactureing 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, was reviewed and states the following: 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup states: while supporting the aquabeam handpiece, gently grip the middle of the semi-rigid section of the aquabeam scope and partially insert through the clear rubber seal on the bottom of the aquabeam handpiece.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.With the proximal key fully retracted, align the scope carriage over the proximal key adapter.Attach to the aquabeam handpiece by pushing the scope carriage forward to engage with the carriage track.Using the knobs on the carriage, advance the aquabeam scope forwards (distal) and backwards (proximal) to ensure that the aquabeam scope is fully engaged with the aquabeam handpiece.The scope tube tip should move forwards and backwards in concert with the movement of the aquabeam scope.Advance the aquabeam scope forward to its fully distal position.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.Confirm the aquabeam scope is fully engaged by advancing and retracting the scope proximal key and observing the scope tube tip moving in concert with the aquabeam scope.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech drive; san jose, CA 95134 ; 6502327291
• MDR Report Key: 18722149
• MDR Text Key: 336631754
• Report Number: 3012977056-2024-00029
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male