MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABEAM ROBOTIC SYSTEM; FLUID JET REMOVAL SYSTEM

Catalog Number AB2000

Device Problem Insufficient Information (3190)

Patient Problem Sexual Dysfunction (4510)

Event Date 08/03/2023

Event Type  malfunction  

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

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during the examination of the prostatic fossa post aquablation procedure, the surgeon observed that the verumontanum (veru) had been inadvertently resected by the waterjet, which may lead to the patient experiencing ejaculatory dysfunction (per the manufacturer's instructions for use, sexual dysfunction, including ejaculatory and erectile dysfunction are potential perioperative risks of the aquablation procedure).The treating surgeon was to monitor the patient's condition in the coming weeks.Procept has requested additional information regarding the current evaluation of the patient's condition.

Manufacturer Narrative

H.3 device evaluation by manufacturer: the aquabeam robotic system is a re-usable device which is still in use at the user facility.The investigation consisted of the information received, plus a review of the treatment log files, device history record (dhr), and labeling.The aquabeam robotic system's treatment logs file was reviewed, which showed that the veru protection zone was adjusted to a very conservative position.The veru aligns at approximately the 10mm mark and the veru zone is around the 25mm mark.The logs also showed that the butterfly was activated.Without a recording of the cystoscopy, no additional comments can be made.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 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: sexual dysfunction, including ejaculatory and erectile dysfunction.A root cause for the reported event could not be determined.The aquabeam robotic system instructions for use list ejaculatory dysfunction as a potential risk of the aquablation procedure.Based on the event details plus a review of the dhr, and ifu the event is considered not to be device-related.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr.; suite 101; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr.; suite 101; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr.; suite 101; san jose, CA 95134 ; 6502327291
• MDR Report Key: 17638744
• MDR Text Key: 322133961
• Report Number: 3012977056-2023-00142
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20221004H
• 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: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

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: Not provided
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 10/22/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2022
• 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 Sex: Male