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 Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 04/13/2023

Event Type  Injury  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that post aquablation procedure, while the patient was being extubated, the patient lost their pulse.A code blue was initiated, and the patient received chest compressions.The patient was revived and taken into the pacu for additional testing and observation.Through a follow-up conversation with the treating surgeon on (b)(6) 2023, procept confirmed that there is no indication that the event was due to the waterjet resection of the prostate, and further investigation was being conducted to determine the origin of the event.On (b)(6) 2023, procept confirmed through the treating surgeon that the patient was admitted overnight for observation and discharged home the following day.An ekg (electrocardiogram), chest x-rays, and testing of troponin levels were conducted, which were all normal.The origin of the patient coding was determined to be possibly related to extubating post-anesthesia.No malfunction of the aquabeam robotic system was reported during this event.

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is curently in-process.Submission of this report does not constitute an admission that the manufacturer's product caused or contribute to the event.

Manufacturer Narrative

The aquabeam robotic system is a reusable device; therefore, it is still currently in 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's instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 3.Contraindications: do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use.A root cause for the reported event could not be determined.The treating surgeon reported that there was no indication that this event was due to the waterjet resection of the prostate and was possibly related to extubating post-anesthesia.The ekg (electrocardiogram) and troponin tests were reported normal, and the patient was discharged the next day.The reported event is unrelated to any alleged deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the aquabeam robotic system.Based on the event details plus a review of the treatment log files, 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.

• 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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065
• MDR Report Key: 16910755
• MDR Text Key: 314990502
• Report Number: 3012977056-2023-00066
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190603N
• 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: 06/22/2023

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
• Device Operator: Health Professional
• Device Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2019
• 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