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

Model Number AB2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Retention (2119)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

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 became aware that five (5) post-procedure the patient reported experiencing urinary retention (per the manufacturer's instructions for use, urinary retention is a potential perioperative risk of the aquablation procedure).No malfunction of the aquabeam robotic system was reported during the aquablation procedure.Additional information is being requested on this event, including current patient's condition.

Manufacturer Narrative

H.10 additional narrative/data: through a follow-up with the treating physician procept biorobotics was only able to confirm that there were no concerns with the patient.No further information was provided by the treating physician.The patient was directly contacted by procept biorobotics for additional details without success.Procept was unable to determine which log file belong to the patient involved in this event; therefore, a review of the log files for the two (2) procedures performed on (b)(6) 2020 was conducted.A review of the aquabeam robotic system's log files confirmed no malfunctions during the aquablation procedure.The review indicated that the system functioned as designed.A review of the device history record (dhr) for ab2000-b rev b/serial number (b)(6) 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 for similar complaints under ab2000-b/serial number (b)(6) confirmed one (1) other similar event.A review of similar complaints across all lots confirmed a total of four (4) similar events.The aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 4.3.Warnings: procedure.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o urinary retention.A root cause for the reported event could not be determined.The aquabeam robotic system's ifu lists urinary retention as a potential risk of the aquablation procedure.Based on the review of the log file, dhr and ifu, the event is considered not to be device related.No further information could be obtained by proceopt biorobotics.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
• MDR Report Key: 10759863
• MDR Text Key: 213914255
• Report Number: 3012977056-2020-00056
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other