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

Model Number AB2000

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that the aquabeam scope was unable to be inserted into the aquabeam handpiece during the aquablation procedure.The handpiece was replaced with a new handpiece unit, but the same issue was encountered.The treating physician proceeded to abort the aquablation procedure and converted to a transurethral resection of the prostate (turp) surgical procedure.

Manufacturer Narrative

H10 additional manufacturer narrative: the aquabeam handpiece was returned for investigation.The telescoping tube on the handpiece was manually moved back and forth; excessive force or resistance was observed.A known-functioning carriage and scope were attached onto the complaint handpiece.Insertion of the scope, both manually and with the carriage, resulted in no issues found; no resistance and did not need to apply excessive force.The scope was able to translate back and forth with ease and functioned as intended.Additionally, a weight was hung from the scope tip and the scope was articulated fully back and forth.The reported issue could not be confirmed and the handpiece was found to be functioning as intended.A review of the device history record (dhr) for serial number (b)(6) and the aquabeam handpiece / lot number 20c00635 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 and its associated component met all design and manufacturing specifications when released for distribution.A review of similar complaints confirmed one (1) similar event reported to procept.Aquabeam robotic system user manual, um0104-00 rev.F, was reviewed and states the following: 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup hold the distal end of the scope tube tip approximately 1 inch (2.54 cm) from the fully proximal position and continue advancing the aquabeam scope forward until it is properly engaged with the aquabeam handpiece and then rotate the proximal key alignment adapter so that the dimple on the proximal key alignment adapter is facing up.An audible click should be heard when the aquabeam scope is securely engaged with the aquabeam handpiece.A root cause for the reported event was unable to be established.The in-house investigation did not identify any potential issues with the returned handpiece that could have contributed to the reported event.Complaint data is monitored and trended as part of procept's quality management system.Shall a trend arise for this failure mode, then further actions will be considered.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: 12457284
• MDR Text Key: 280688825
• Report Number: 3012977056-2021-00069
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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