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

Model Number AB2000

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware post aquablation procedure, after hemostasis was completed, a bladder perforation was observed with the patient (per manufacturer's instructions for use, prostate bladder perforation is a perioperative risk of the aquablation procedure).The perforation was into the fatty tissue of the bladder and did not appear to have occurred due to the resection with the high-velocity sterile saline waterjet during the aquablation procedure.It was later confirmed through discussion with the treating physician and resident that the bladder perforation may have occurred due to use of excessive force with either the aquabeam handpiece during the aquablation procedure or resectoscope during hemostasis.In response to the bladder perforation, the treating physician left a foley balloon catheter in place longer to allow for healing of the perforation (physician did not specify length of time).No malfunction of the aquabeam robotic system was reported during this event.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware post aquablation procedure, after hemostasis was completed, a bladder perforation was observed with the patient (per manufacturer's instructions for use, prostate bladder perforation is a perioperative risk of the aquablation procedure).The perforation was into the fatty tissue of the bladder and did not appear to have occurred due to the resection with the high-velocity sterile saline waterjet during the aquablation procedure.It was later confirmed through discussion with the treating physician and resident that the bladder perforation may have occurred due to use of excessive force with either the aquabeam handpiece during the aquablation procedure or resectoscope during hemostasis.In response to the bladder perforation, the treating physician left a foley balloon catheter in place longer to allow for healing of the perforation (physician did not specify length of time).No malfunction of the aquabeam robotic system was reported during this event.

Manufacturer Narrative

Additional manufacturer narrative: root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam robotic system was not returned for investigation of this event and is currently in use at the user facility.The investigation consisted of a review of the information received through the treating physician, a review of the device history record, labeling and similar events reported to procept.A review of the device history record (dhr) ab2000-b rev.G/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 were reviewed and state the following: 4.3 warnings: procedure.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bladder or prostate capsule perforation.5.6 precautions: procedure.Ensure the aquabeam handpiece nozzle is in desired resection area prior to depressing the foot pedal.Failure to do so may result in bladder perforation, urinary sphincter injury, and/or erectile dysfunction.A similar complaint review for a 12-month perioud was conducted, which confirmed no other similar event have been reported to procept.According to the event details the bladder perforation may have occurred as a result of the surgeon being too aggressive either with the handpiece or resectoscope during entry into the bladder.The aquabeam robotic system's ifu contains adequate instructions warning the user to ensure that the aquabeam handpiece nozzle is in the desired resection area prior to depressing the foot pedal to avoid a bladder perforation.Based on the information received plus the in-house investigation, 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 94065 1494
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 13194913
• MDR Text Key: 286257532
• Report Number: 3012977056-2022-00002
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: 00+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,Followup
• Report Date: 08/15/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male