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 Problems Hemorrhage/Bleeding (1888); Urinary Retention (2119); Patient Problem/Medical Problem (2688)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

Product return is not available as the system in currently in use at the user facility.Investigation by manfacturer 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 two (2) days post-aquablation procedure, and removal of the foley balloon catheter, the patient was taken back to the operating room (or) due to urinary retention (per manufacturer's instructions for use, urinary retention is perioperative risk of the aquablation procedure).A new foley balloon catheter was inserted for two (2) additional days; however, the patient continued to show urinary retention symptoms.The patient was taken back to the or for transurethral resection of the prostate (turp) surgery.Information received from the treating physician indicated that the event was not due to a malfunction of the aquabeam robotic system, as the patient continued to have urinary retention post-turp procedure.

Manufacturer Narrative

The aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the log file indicated that the system functioned as designed.A review of the device history record (dhr) serial number (b)(6) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications upon release for distribution.A review for similar complaints was performed on serial number (b)(6), which confirmed that there were no other similar events.A review across all lots found a similar event.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, was reviewed and urinary retention is listed as a potential perioperative risk of the aquablation procedure.A root cause for the reported event could not be determined.Urinary retention is 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.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 two (2) days post-aquablation procedure, and removal of the foley balloon catheter, the patient was taken back to the operating room (or) due to clot retention (per manufacturer's instructions for use, bleeding is perioperative risk of the aquablation procedure).A new foley balloon catheter was inserted for two (2) additional days; however, the patient continued to show retention symptoms.The patient was taken back to the or for transurethral resection of the prostate (turp) surgery.Information received from the treating physician indicated that the event was not due to a malfunction of the aquabeam robotic system, as the patient continued to have urinary retention post-turp procedure.

Manufacturer Narrative

H.11 corrected data: 1) b5.Describe event or problem - please refer to updated description of event.2) h.6 event problem evalucation codes.The correct health effect - clinical code is "1888 - hemorrhage/bleeding".3) h.10 additional manufacturer narrative: the aquabeam robotic system's instructions for use (ifu), ifu0104-00, was reviewed and bleeding is listed as a potential perioperative risk of the aquablation procedure.A root cause for the reported event could not be determined.Bleeding is 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.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

H.11 corrected data: h.1 type of reportable event: the follow-up #1 was incorrectly reported as an malfunction.The correct selection should have been serious injury.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: 10255818
• MDR Text Key: 199313679
• Report Number: 3012977056-2020-00021
• 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,Followup,Followup
• Report Date: 05/21/2021

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: 06/09/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 10/02/2020; 04/15/2021; 05/21/2021
• Supplement Dates FDA Received: 10/12/2020; 04/23/2021; 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention