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

Catalog Number AB2000

Device Problem Infusion or Flow Problem (2964)

Patient Problem Perforation (2001)

Event Date 11/22/2023

Event Type  Injury  

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

A male patient with a 107g prostate underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the first treatment pass, the aquabeam handpiece high-velocity waterjet resected the prostatic tissue abnormally deeper than the originally planned resection angles by the treating surgeon; however, the high-velocity waterjet quickly returned to normal.The treating surgeon proceeded with aquablation therapy and completed a total of 2.5 passes.After removing the aquabeam handpiece and while looking in the patient with the resectoscope, the treating surgeon observed that a ureteral orifice was perforated.A stent was placed to treat the perforation.

Manufacturer Narrative

The aquabeam robotic system is a reusable device; therefore it is currently in the possession of the user facility.The investigation of this event consisted of a review of the event treatment logs, device history record (dhr) and procept's risk documentation.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.Although the aquabeam robotic system labeling does not specifically mention damage to ureteral orifices, procept's risk management documentation includes damage to ureteral orifices as a clinical effect of the aquablation procedure.A review of the event logs revealed very little high velocity waterjet activity beyond the bladder neck inside of the bladder.Damage to the ureteral orifices would not have been predicted unless they were in an atypical location adjacent to the bladder neck.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.Although the aquabeam robotic system labeling does not specifically mention damage to ureteral orifices, procept's risk management documentation includes damage to ureteral orifices as a clinical effect of the aquablation procedure.Based on the event details and a review of the event treatment logs, dhr, and procept's risk documentation, 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; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech drive; san jose, CA 95134
• MDR Report Key: 18351632
• MDR Text Key: 330815876
• Report Number: 3012977056-2023-00232
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/$$722C00099/16D20220121D
• 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: 03/01/2024

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?: Yes
• 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: 11/22/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Male