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 Hemorrhage/Bleeding (1888)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

Product return is not available as the system in currently in use at the user facility.Investigation by manfacturer is currently in-process.

Event Description

A male patient underwent an aquablation procedure.Post procedure, the patient was taken back to the operating room to treat an arterial bleeding at the bladder neck (per manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure), which had been previously resected and cauterized as part of the aquablation procedure (recommended method by the manufacturer's instructions for use to achieve hemostasis), but had opened up.Cauterization of the bladder neck was performed to control the bleeding without any further clinical sequela to the patient.The patient was reported to be in good condition.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

A review of the system's log file was conducted, which confirmed that there were no malfunctions observed during the procedure.No system malfunctions were observed.A review of the device history record (dhr) for the aquabeam system, serial number (b)(6) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system, which could relate to the reported event.The review indicated that the system met all required specifications when released for distribution.A review for similar events was conducted on the aquabeam system, serial number (b)(6), which confirmed that there one (1) similar event that have been reported on this system.The aquabeam system's instructions for use (ifu), ifu0104-00, was reviewed and bleeding is listed as a potential perioperative risk of the aquablation procedure.The system was not returned for investigation of this complaint.Bledding is a potential risk of the aquablation procedure.Based on the review of the log file, 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
• MDR Report Key: 10203768
• MDR Text Key: 199313481
• Report Number: 3012977056-2020-00017
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• 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
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention