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

Model Number AB2000

Device Problem Optical Problem (3001)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

A root cause for the reported event is yet to be determined; investigation by the 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 that during the aquablation procedure the aquabeam scope visualization fiber was broken and had to be replaced to continue the procedure through successful completion.The reported event caused a surgical procedural delay of over 40 minutes.There were no adverse health consequences with the patient because of this event.

Manufacturer Narrative

H10: additional manufacturer narrative: the aquabeam scope was returned for investigation.The reported aquabeam scope visualization fiber being broken could not be confirmed.The scope was returned in one (1) piece.Further investigation confirmed a visualization issue when looking through the eyepiece no image could be seen.The image was completely black indicating that the visualizatio fiber (fiber optic) was broken.A review of the device history record (dhr) for serial number (b)(6) and the lot number 2011 for the aquabeam scope were 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 the aquabeam scope met all design and manufacturing specifications when released for distribution.A review of similar complaints for fiber optic breaks confirmed 17 other similar events have been reported to procept.The 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: verify the aquabeam scope visualization via the camera source port.Note: obtain a new aquabeam scope if proper visualization cannot be verified.The reported event of a broken scope was not confirmed; however, additional analysis confirmed a broken fiber optic on the returned scope, which caused no image.The root cause was unable to be conclusively determined.Procept has identified a trend in visualization issues with the aquabeam scope, which are currently being addressed through the corrective action and preventive action process.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 ; 6502327291
• MDR Report Key: 12389297
• MDR Text Key: 270824122
• Report Number: 3012977056-2021-00066
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: 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: 01/13/2022

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: 08/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2020
• 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