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 Hemorrhage/Bleeding (1888)

Event Date 03/01/2024

Event Type  Injury  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that post aquablation procedure, the patient was taken back to the operation room to address bleeding.The treating surgeon spent approximately 10-15 minutes unroofing clots circumferentially at the bladder neck to help identify any bleeding arteries.It was reported that a mild bleed located at 6 o'clock on the bladder neck was most likely the cause of the bleeding.The bleeding was addressed with cautery.It was reported that the patient is currently doing great and has been discharged.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

Root cause of the 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

N/a.

Manufacturer Narrative

The aquabeam robotic system was not returned, and it is currently in use at the user facility.The investigation of this event is based on the information received, plus a review of the device history record, and ifu.A review of the device history record (dhr) for ab2000-b rev.G/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 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: 4.3.Warnings: procedure.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bleeding.A root cause for the reported event could not be determined.The patient was taken back to the or for post procedural bleeding.The aquabeam robotic system instructions for use list bleeding as a potential risk of the aquablation procedure and provides adequate instructions on how to achieve appropriate hemostasis.Based on the review of the information provided, plus a review of the dhr and ifu, this 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 dr; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose, CA 95134
• MDR Report Key: 19001093
• MDR Text Key: 338878588
• Report Number: 3012977056-2024-00078
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: 12309232123C03
• UDI-Public: 01008500555427020112309232123C03677
• 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: 03/28/2024

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: 03/04/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2023
• 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