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 Bradycardia (1751)

Event Date 04/04/2024

Event Type  Injury  

Event Description

A male patient underwent aquablation therapy for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that while in the post anesthesia care unit (pacu), the patient experienced bradycardia.The rapid response team was called and the patient was administered epinephrine which resolved the issue.It is believed that the patient experienced an allergic reaction to dilaudid in the pacu, resulting in the reported bradycardia.It was reported that the patient has been discharged from the hospital and is doing "fine".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 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.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.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.It was reported that while the patient was in the post anesthesia care unit (pacu), his heart vitals declined.It was determined that the patient had an allergic reaction to pain medication in the pacu, resulting in bradycardia.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; 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: 19199057
• MDR Text Key: 341239907
• Report Number: 3012977056-2024-00105
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20221222B
• 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
• Report Date: 04/28/2024

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: 04/05/2024
• Initial Date FDA Received: 04/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2022
• 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