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

Model Number AB2000

Device Problem Mechanical Problem (1384)

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

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

The aquabeam robotic system scope was returned for investigation.Visual inspection of the returned scope confirmed that the semi-flexible stainless steel hypotube was broken in two (2) pieces near the proximal key adapter location.Additionally, two (2) significant kinks in the semi-flexible stainless steel hypotube were observed near the proximal key adapter location.The break was determined to be consistent with encountering resistance to translating the scope carriage at the proximal end of travel, causing the scope to buckle and break.A review of the manufacturing records was performed and no issues that could have contributed to this event were found.Furthermore, the review of the manufacturing records did not identify any failure of the product to meet its material, assembly or performance specifications.A review for similar events identified a total of seven (7) complaints that have been reported similar to this event.Based on the investigation, the most probable root cause has been determined to be consistent with encountering resistance to translating the scope carriage at the proximal end of travel, causing the scope to buckle and break.In efforts to prevent the reported event from recurring, procept is currently in the process of revising the aquabeam® robotic system instructions for use to include instructions for the operator to reposition the handpiece in case excessive resistance is encountered during the scope positioning in order to reduce the chance of damaging the scope.

Event Description

A male patient underwent an aquablation procedure.It was reported that during treatment the aquabeam robotic system scope broke, which caused a 30-minute procedural delay.The scope was replaced and the aquablation procedure continued to completion.There were no adverse health consequences with the patient because of this 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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city, ca
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 170; redwood city, ca ; 2327291
• MDR Report Key: 10027205
• MDR Text Key: 199314501
• Report Number: 3012977056-2020-00013
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 05/05/2020

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2020
• Initial Date FDA Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2019
• 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