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

Catalog Number AB2000

Device Problem Visual Prompts will not Clear (2281)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

H6.Health effect clinical code = 4581: mild bleeding due to hemorrhoid.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 underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during jet alignment, the aquabeam robotic system generated an "e22 - motorpack error".Multiple troubleshooting steps to clear the error were unsuccessful.A second aquabeam handpiece was used which resolved the error.The treating surgeon proceeded with the aquablation procedure and during the first treatment pass, the patient moved significantly enough that required removal of the aquabeam handpiece and the ecbp-1 trus probe.Once the ecbp-1 trus probe was removed, blood was noted, which the treating surgeon attributed to a hemorrhoid near the anus.No intervention was needed for the bleeding.The treating surgeon proceeded to convert the procedure to transurethral resection of the prostate (turp).It was reported that the patient was discharged with no further concerns.

Manufacturer Narrative

H.11 additional manufacturer narrative: the aquabeam handpiece was not returned as it was discarded at the user facility.Therefore, the root cause of the reported event could not be established.A review of the device history record (dhr) for the aquabeam robotic system/serial number (b)(6) and aquabeam handpiece/ lot number 23c11129 was conducted, which confirmed that there were two (2) non-conformances issued to this lot during the manufacturing process that could potentially be related to the reported failure.The lot was segregated and affected units were reworked and re-inspected as part of our handpiece final inspection process.Upon re-inspection, the lot met all required specifications and was deemed acceptable to be released for distribution.The aquabeam robotic system user manual, um0101 rev.F, states the following: table 5: system detected errors and faults.E22 - motorpack error.Release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece.E31 - motorpack error.Release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece.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 dr; 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 ; 6502327291
• MDR Report Key: 19001100
• MDR Text Key: 338936418
• Report Number: 3012977056-2024-00084
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/$$722C03603/16D202210037
• 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: 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 03/07/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2022
• 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