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

Catalog Number AB2000

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

Patient Problem Perforation (2001)

Event Date 02/15/2024

Event Type  Injury  

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 Description

A male patient with a large prostate ranging from 300-350 grams underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedure, the treating surgeon started at the mid-prostate, working back to the veru protection zone in segments with one final treatment pass started at the bladder neck.It was reported that once the aquablation procedure was completed and the foley balloon catheter was inserted into the bladder and drapes were removed, the patient's abdomen was noted to be very distended.Upon seeing this, the anesthesiologist mentioned that his peak flow spiked 5 minutes prior.The treating surgeon suspected bladder perforation and proceeded to begin the second surgery to relieve 5-6 liters of fluid and repair the bladder.The perforation was found slightly anterior on the patient's right side of the dome of the bladder.The patient is reported to be stable and doing well.The cause of bladder perforation is undetermined.On march 11, 2024, the patient was reported to be recovering well and is expected to be discharged soon.There were no reported malfunctions of the aquabeam robotic system.No additional information has been provided at this stage.

Manufacturer Narrative

Additional information received on 14-mar-2024 indicating that during case review with the treating surgeon and a second surgeon, it was determined that the bladder perforation was not caused by the aquabeam waterjet and occurred after.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 event log files, device history record (dhr), and instructions for use (ifu).A review of the device history record (dhr) ab2000-b/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: bladder or prostate capsule perforation.The aquabeam robotic system was not returned for investigation of this complaint.The treating surgeon determined that the issue was not caused by the waterjet.The aquabeam robotic system's ifu lists bladder perforation as a potential risk of the aquablation procedure.Based on the information obtained through the treating surgeon plus a review of the event log files, dhr, and ifu, the event is considered not 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
• Type of Device: 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 dr; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose, CA 95134 ; 6502327291
• MDR Report Key: 18896806
• MDR Text Key: 337583467
• Report Number: 3012977056-2024-00060
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D202210038
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

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 Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male