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

Model Number HP2000

Device Problem Connection Problem (2900)

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

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation difficulty was encountered latching the aquabeam scope into the aquabeam handpiece.Several troubleshooting steps were performed without resolving the issue.The aquabeam handpiece was replaced with a new handpiece unit and the aquablation procedure was able to be successfully completed.The reported event caused a procedural delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam handpiece was returned for investigation.The associated aquabeam scope was not returned for investigation.Functional investigation confirmed the reported difficulty to latch the returned handpiece with a known good scope.The distal feature of the scope that latches inside the cavity of the scope tip on the handpiece was measured and was found to be within specification (0.168-0.172 inches).The latch mechanism on the handpiece was observed under the microscope and no abnormalities were seen.The scope tip was removed from the handpiece and studied under the microscope, no obstructions or anomalies were seen that could block the passage of the scope.Hence, the reported failure was confirmed; however, the root cause could not be established.A review of the device history record (dhr) for serial number (b)(6) and the aquabeam handpiece / lot number 19c01645 was performed, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system and its associated component met all design and manufacturing specifications when released for distribution.A review of similar complaints confirmed no other other similar events reported to procept.Aquabeam robotic system user manual, um0104-00 rev.F, was reviewed and states the following: section 11.2.4, aquabeam handpiece and aquabeam scope setup preparation, contains instructions to, "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." the root cause of the reported event was unable to be established; however, a corrective action and preventive action (ca/pa) had been initiated that addresses this failure mode; however, the device involved in this event was confirmed to have been built prior to implementation of actions per the capa.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; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 13049198
• MDR Text Key: 289197315
• Report Number: 3012977056-2021-00104
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/29/2022

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 Model Number: HP2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 03/22/2022
• Supplement Dates FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male