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 Ulcer (2274); Gastrointestinal Hemorrhage (4476)

Event Date 06/08/2022

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

Procept biorobotics corporation (procept) became aware that an 85-year-old male patient with an approximately 300-cc prostate size and known cancer 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).Post aquablation procedure, the patient experienced gastrointestinal (gi) problems at which point a ct scan was performed and found no anomalies.The patient's gi problems were resolved and was discharged home.Seven (7) days post-aquablation procedure, the patient had an emergency call and passed away on the way to the emergency room.Through a follow-up conversation with the treating physician, procept confirmed that the patient began vomiting blood leading to the patient coding a week after the aquablation procedure.Per the information obtained through the treating physician, the autopsy report listed the primary cause of death as an undiagnosed chronic esophageal ulcer.The treating physician confirmed that the event was unrelated to the aquablation procedure or a malfunction of the aquabeam robotic system.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam robotic system was returned for investigation as it remains in use at the user facility.The investigation consisted of the information obtained through a conversation with the treating surgeon, plus review of the treatment log files, device history record (dhr), and labeling.The aquabeam robotic system's treatment log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the treatment log file indicated that the system functioned as designed.A review of the device history record (dhr) for aquabeam robotic system ab2000-b rev d/serial number (b)(6) was performed, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system and its associated component 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.Investigation of the treatment log files, device history record, labeling/ifu, and information received through the treating surgeon confirmed that no device malfunction occurred and the aquabeam robotic system functioned as intended and was used in accordance with its instructions for use.The reported event was determined 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 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: 15136551
• MDR Text Key: 296942652
• Report Number: 3012977056-2022-00096
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190916T
• 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: 10/03/2022

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: 06/30/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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: 85 YR
• Patient Sex: Male