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

Model Number AB2000

Device Problems Mechanical Problem (1384); Failure to Align (2522)

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

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: root cause is not yet determined, investigation is currently underway.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 (procep) became aware that difficulty was encountered locking the aquabeam scope into the aquabeam handpiece.The aquabeam handpiece was replaced with a new handpiece unit and the aquablation procedure was continued through successful completion.The reported event caused a surgical procedural delay of over 20 minutes.There were no adverse health consequences to the patient due to the procedural delay.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam handpiece returned for investigation.The handpiece was observed to have no physical damages or anomalies.The handpiece z-position was observed to be at approximately 59mm which would indicate that the handpiece was docked.Additionally, the telescoping tube was fully extended and the jet probe was seated behind it.Upon inserting a qa scope, the scope was unable to be fully inserted as the returned handpiece's jet probe was blocking the opening of the telescoping tube.The telescoping tube was then manually retracted back to the intended position and the handpiece z-position set to 70mm as per the um0101-00 rev.F, aquabeam robotic system user manual, us, english.The qa scope was then able to be fully inserted and translates without issue.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam handpiece / lot number 22c00911 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.Aquabeam robotic system user manual, um0101-00 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.The root cause is use error as it is likely that the customer did not follow the user manual steps which instructs the user to "retract the scope tube tip on the aquabeam handpiece to 1 inch (2.54 cm) in front of its fully proximal position." before docking the handpiece and translating back and forth.This is further evidenced by the handpiece z-position at 59mm upon receipt which is indicative of being docked before inserting a scope and the telescoping tube observed to be fully extended past the jet probe.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: 15415113
• MDR Text Key: 306243080
• Report Number: 3012977056-2022-00118
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20220318C
• 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: 09/16/2022

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 Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/18/2022
• 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