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

Catalog Number AB2000

Device Problem Break (1069)

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

Event Date 09/06/2023

Event Type  malfunction  

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.

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, the aquabeam scope had a broken lens which was then replaced by the second aquabeam scope.It was reported that when the aquabeam handpiece was inserted inside the patient with the second aquabeam scope, the scope lens broke.As a result, a new handpiece was opened and the procedure was continued through successful completion.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

The aquabeam scope was returned for investigation.Visual inspection was able to confirm the reported event as the scope was observed to have multiple crimps along the semi-flexible hypotube and is broken into two pieces.The root cause is undeterminable; however, it is likely that it was caused by excessive pressure being applied to the scope.The issue has been addressed as part of procept's quality management system.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam scope / lot number 72006/s0024 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 was reviewed.Um0101-00 rev.F 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup states: -hold the distal end of the scope tube tip approximately 1 inch (2.54cm) 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.11.2.21 aquabeam robotic system disassembly -retract the scope carriage to the proximal end to remove the aquabeam scope from the aquabeam handpiece.-simultaneously depress the tab at the bottom of the aquabeam handpiece and push the scope carriage off the track.-rotate the scope proximal key adapter until grooves are perpendicular to the aquabeam handpiece track.-holding the aquabeam handpiece scope tube tip, rotate the scope proximal key adaptor about 30 degrees clockwise and counterclockwise while pulling the aquabeam scope out of the aquabeam handpiece.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

The associated aquabeam handpiece was not returned for investigation.The root cause of the reported event could not be established because the handpiece was not returned for investigation, and it could not be determined if the associated aquabeam handpiece contributed to the event.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 22c00156 was conducted, which confirmed that there was one (1) non-conformance issued to this lot during the manufacturing process that could potentially be related to the reported event.The affected units within the lot were reworked to address the nonconformance.Upon re-inspection, the lot met all required specifications and was then deemed acceptable to be released for distribution per device specifications.Submission of this report does not constitue 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 dr; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose, CA 95134 ; 6502327291
• MDR Report Key: 17794964
• MDR Text Key: 324018108
• Report Number: 3012977056-2023-00156
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 10/03/2023; 03/14/2024
• Supplement Dates FDA Received: 10/17/2023; 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2020
• 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