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

Model Number AB2000

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

A root cause for the reported event has not yet been determined; device evaluation is currently in-process.

Event Description

A male patient underwent an aquablation procedure.It was reported that during set-up process, while priming, system errors messages "e02 hpp high rpm" and "e03 hpp low rpm" were displayed and could not be cleared; therefore, the procedure was aborted.The physician proceeded to perform a transurethral resection of the prostate (turp) to treat the patient's benign prostatic hyperplasia (bph).There were no adverse health consequences as a result of the event.

Manufacturer Narrative

Additional manufacturer narrative: the aquabeam console (console) was returned for investigation.The initial investigation was able to reproduce system error messages "e02 hpp high rpm" and "e03 hpp low rpm"; however, during further investigation, the errors were lost.The errors were reproduced after running the aquabeam console at 100% pump power for 45-50 minutes.The encoder wheel was determined to have become warped, likely due to localized heat from friction.A review of the aquabeam robotic system's log file was conducted, which confirmed system errors messages "e02 hpp high rpm" and "e03 hpp low rpm" were generated and could not be cleared.The procedure was discontinued.A review of similar events was conducted, which confirmed no other events have been reported.The aquabeam robotic system user manual (intl), um0104-00, rev c., under table 5: system detected errors and faults contains the following information: e02 - console error.Release foot pedal and click x.If error persists, turn off and turn on console.And "e03 - console error.Release foot pedal and click x.If error persists, turn off and turn on console." due to the loss of failure mode during the investigation, as well as the subsequent irregular waveform pattern replicated after running the aquabeam console at high power, the likely cause of the reported event is encoder wheel misalignment; however, the root cause of the encoder wheel misalignment was unable to be determined.This is the first occurrence of this event.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
• MDR Report Key: 9803075
• MDR Text Key: 191588988
• Report Number: 3012977056-2020-00009
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

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
• Device Lot Number: 19C00725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1