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

Model Number 320301

Device Problem Nonstandard Device (1420)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019, as part of the aquablation procedure setup phase, a handpiece went through our standard priming process prior as part of the preparation phase before the procedure.E22 (r motion error) message was triggered during the priming.The handpiece was disconnected and returned to the manufacture for failure analysis.The handpiece was received by the manufacturer on 27mar2019.Since the handpiece was not used, the initial reportability assessment determined this as not a reportable event as the malfunction was found by the user prior to its use.When the system detects this failure, it immediately renders the handpiece inoperable by triggering the e22 error and notifies the user on the aquabeam conformal planning unit (cpu).Failure investigation for this complaint was completed on 28mar2019.It was determined that the failure mode was caused by an internal leak in the handpiece due to a micro-crack in a specific weld joint within the assembly.Based on the fact that there were previous complaints that were filed for the same failure mode that caused procedural delays, and those were reported as mdrs, the manufacturer has elected to report this complaint as an mdr based on the completed complaint analysis information.

• Brand Name: AQUABEAM SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS; 900 island drive, suite 101; redwood city 94065
• Manufacturer Contact: lingli li ; 900 island drive, suite 210; redwood city 94065 ; 6502327215
• MDR Report Key: 8467204
• MDR Text Key: 146081852
• Report Number: 3012977056-2019-00014
• Device Sequence Number: 1
• Product Code: PZP
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/29/2019

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 Expiration Date: 08/31/2020
• Device Model Number: 320301
• Device Lot Number: 18C00799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1