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

Catalog Number	AB2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	07/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause of the reported event has not yet been established.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 or Problem Description
A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that post-aquablation treatment, the patient experienced a urinary tract infection which was treated with medication and catheterization.The treating surgeon confirmed that the aquabeam robotic system functioned as intended, and assessed the event to be related to the procedure.No malfunction of the aquabeam robotic system was reported.
Additional Manufacturer Narrative
The aquabeam robotic system is a reusable device; therefore, it is currently in the possession of the user facility.The investigation of this event consisted of a review of the device history record (dhr) and labeling.A review of the device history record (dhr) (b)(4)/serial number (b)(6) was conducted, which confirmed that there were no non-conformances, 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.Aquabeam robotic system 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: infection.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The treating surgeon confirmed that the aquabeam robotic system functioned as intended and assessed the event to be related to the procedure.The aquabeam robotic system's ifu lists infection as a potential risk of the aquablation procedure.Based on the review of the dhr and labeling, 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.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Common Device Name: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech drive; san jose, CA 95134
• MDR Report Key: 17952408
• Report Number: 3012977056-2023-00168
• Device Sequence Number: 7669760
• Product Code: PZP
• UDI-Device Identifier: B614AB2000C1
• UDI-Public: +B614AB2000C1/16D20220330O
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: DEN170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male