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 02/05/2020

Event Type  Injury  

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 robotic system, lot number 19c00267, 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 robotic system, lot number 19c00267, which confirmed that there were no other similar events reported on this system.The aquabeam system's instructions for use (ifu), ifu0101, rev.C, 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.Bleeding 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.

Event Description

A male patient underwent an aquablation procedure.Per standard post-aquablation procedure, focal cauterization was performed, and the surgeon decided to administer tranexamic acid (txa) to address bleeding and the patient was transferred to the post-anesthesia care unit (pacu).The patient was later taken back to the or for persistent bleeding (per manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure).The patient presented with an arterial bleeder at the bladder neck as well as an untreated median lobe.Cauterization of the area was performed to stop the bleeding.The patient received two (2) units of blood transfusion and discharged home two (2) days post-aquablation procedure without any clinical sequela.No malfunction of the aquabeam robotic system was reported.

• 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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city, ca
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 170; redwood city, ca ; 2327291
• MDR Report Key: 9803073
• MDR Text Key: 188337366
• Report Number: 3012977056-2020-00010
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• 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: 03/06/2020

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
• Device Lot Number: 19C00267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2019
• 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