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

Model Number AB2000

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause of the reported event has not yet been determined.Investigation is currently in-process.

Event Description

A male patient underwent an aquablation procedure.It was reported that during treatment the aquabeam robotic system scope broke, which caused a 25-minute procedural delay.The scope was replaced and the aquablation procedure continued to successful completion.There were no adverse health consequences to the patient because of this event.

Manufacturer Narrative

The aquabeam robotic system scope was returned for investigation.Visual inspection confirmed a break in the flexible section of the scope at the eyepiece connection joint.The customer reported that the same scope has been utilized in two (2) previous procedures prior to this event and no damage was observed.The aquabeam robotic system scope is a purchased device, which passed receiving inspection prior to release for distribution.The aquabeam robotic system instructions for use, ifu0104-00, under section 5.3.Precautions, states the following: aquabeam scope setup - ensure the aquabeam scope has no sharp edges, rough surfaces, protrusions, and/or damage to the device.A similar complaint review for this lot number indicated that there were no other similar complaints reported.A review across all lot numbers found eight (8) other similar events.Based on the information received by the user and investigation results, the root cause of the reported event may be related to mishandling of the aquabeam robotic system scope prior to the procedure.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
• MDR Report Key: 10151197
• MDR Text Key: 199314591
• Report Number: 3012977056-2020-00016
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• 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: 06/04/2020
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1