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 01/15/2024

Event Type  Injury  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Before the aquablation therapy, the patient was treated for a bladder stone via laser lithotripsy.Post procedure, it was noted that the patient's foley catheter was not draining well.A computed tomography scan found that the patient had a less than one centimeter bladder perforation (per manufacturer's instructions for use, bladder perforation is a perioperative risk of the aquablation procedure).The bladder perforation was treated with a drain and foley catheter (without continuous bladder irrigation).It was reported that the patient "did well" and was discharged.No malfunction of the aquabeam robotic system was reported.

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 treatment log files, device history record (dhr) and labeling.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.The 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 is a reusable device; therefore, it is still currently in possession of the user facility.The device was not returned for investigation because it performed as intended during the aquablation procedure.The aquabeam robotic system instructions for use lists bladder perforation as a potential risk of the aquablation procedure.Based on the information obtained from the treating surgeon plus a review of the treatment log files, 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
• 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 drive; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech drive; san jose, CA 95134
• MDR Report Key: 18697896
• MDR Text Key: 335270462
• Report Number: 3012977056-2024-00025
• Device Sequence Number: 1
• Product Code: PZP
• 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
• Report Date: 02/13/2024

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: Not provided
• Initial Date FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2022
• 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
• Patient Sex: Male