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 Hemorrhage/Bleeding (1888)

Event Date 06/09/2020

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 during the procedure the patient was converted to transurethral resection of the prostate (turp) surgery due to a small size prostate.The patient was later taken back to the operating room due to bleeding, which was addressed by cauterization.The patient was reported to be in good condition.No malfunction of the aquabeam robotic system was reported.

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) for serial number (b)(6) was conducted, which confirmed that there were was a nonconformances generated during the manufacturing process of this system.The nonconformance was reworked to address the issue.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 no other similar events reported on this system.No other similar events have been reported all across all systems.He aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.C, was reviewed and states the following: contraindications: do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use.Warnings: procedure.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o bleeding.The reported event is unrelated to any alleged deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of aquabeam robotic system.The information received by the treating physician indicated that the aquablation procedure was not a good option for this patient's anatomy.Based on the information received by the treating physician, a review of the log file, dhr, and labeling this event is unrelated to the aquabeam robotic system.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: 10255817
• MDR Text Key: 199313194
• Report Number: 3012977056-2020-00023
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• 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
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention