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

Model Number AB2000

Device Problems Connection Problem (2900); Incomplete or Inadequate Connection (4037)

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

Event Date 02/21/2022

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 procedure difficulty was encountered connecting the aquabeam motorpack to the aquabeam handpiece, causing multiple system error messages to occur.The aquabeam handpiece was replaced with a new handpiece unit; however, the issue persisted; therefore, the treating surgeon decided to abort the aquablation procedure.There were no adverse health consequences to the patient due to the reported event.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam handpiece was not returned for investigation.A field service engineer visit at the customer site to further investigate the reported event isolated the issue to the aquabeam motorpack.The motorpack was replaced and returned to procept for investigation.The log files confirmed the reported event as instances of the aquabeam system transitioned to sessionid during the treatment phase were observed.Functional testing could not reproduce the reported issue as the motorpack pcb was accidentally shorted rendering it non-functional.A review of the device history record (dhr) for ab2000/serial number (b)(6), aquabeam handpiece/lot number 20c00415, and aquabeam motorpack/lot number 21c00501 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 met all design and manufacturing specifications when released for distribution.A review of similar complaints for a 12-month period confirmed no other similar events have been reported to procept.The aquabeam robotic system instructions for use, ifu0104-00, was reviewed and states the following: 8.23 sterile align waterjet nozzle by doing the following: b.Press the foot pedal to visualize position of waterjet c.Waterjet needs to be visible at 3 or 9' o clock it is likely that there is an inrush power drop to the motorpack 5 volt when the 24v motorpack motor is rotating, given it occurred always when the r motor is rotating (alignment or treatment).Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.However, the root cause was unable to be established.This is the first occurrence of this issue (b)(4) complaint rate from 25-april-2021 to 25-april-2022).Should a trend arise further actions shall be taken.

• 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: 13870063
• MDR Text Key: 290456391
• Report Number: 3012977056-2022-00024
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190807T
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/06/2022

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: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 04/29/2022
• Supplement Dates FDA Received: 05/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2019
• 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