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 Chest Pain (1776)

Event Date 08/18/2022

Event Type  Death  

Manufacturer Narrative

Root cause of 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

On (b)(6) 2022, an 84-year-old male patient with an approximately 200-cc prostate size and with a clinical history of renal insufficiency and being on zocor medication underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).The aquablation procedure was completed without complications and the foley balloon catheter was clear when the patient left the operating room (or).On (b)(6) 2022, procept biorobotics corporation (procep) became aware that the patient expired on (b)(6) 2022.Through a follow-up conversation with the treating surgeon, procept confirmed that the aquablation procedure was successful without any complications and that the aquabeam robotic system performed as intended.Post-op, the patient passed out in the recovery room, likely due to traction coming off (creatinine levels were 12.7 to 5.9 mg/dl - normal range of 0.7 to 1.3 mg/dl for men).The patient was administered three (3) units of blood and taken back to the operating room with no bleeding observed.The next morning, one (1) day post-op, the patient began having chest pain and had st-segment elevation but was not taken to the catheter lab.On (b)(6) 2022 the patient expired.It was the treating surgeon's opinion that the patient expired due to cardiac reasons and indicated that the patient's relatives were going to decline an autopsy to be performed.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam robotic system was not returned for investigation of this event and is currently in use at the user facility.The investigation consisted of a review of the information reported to procept, plus a review of device history record (dhr) and labeling.Three good faith efforts were made to obtain the log files for this event without success.A review of the device history record (dhr) ab2000-b rev.G/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: 3.Contraindications: do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use.Through a follow-up conversation with the treating physician, procept that the patient' death was unrelated to the aquablation procedure.Based on the information obtained through the treating surgeon plus a review of the dhr and labeling 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; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 15466395
• MDR Text Key: 300402329
• Report Number: 3012977056-2022-00125
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/$$721C00848/16D20210511G
• 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: 11/15/2022

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: 08/26/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR
• Patient Sex: Male