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

Model Number AB2000

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

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

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

Component code: (b)(4).Root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.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 became aware that during the aquablation procedure, the aquabeam console pump cartridge latch mechanism was loose, not allowing the aquabeam handpiece pump cartridge to be securely attached to the console.As a result of this event, the aquablation procedure was aborted.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam console was returned for investigation along with a portion of a aquabeam handpiece pump cartridge.The console was observed to have a handpiece pump cartridge attached which was unable to be removed.Upon further inspection, the console pump cartridge slot was stuck in the lock position.Rotating the pump cartridge latch could not unlock the slot to allow the handpiece pump cartridge to be removed.The console was then deconstructed and it was observed that the helical gear was broken which would prevent the latch to function properly.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam console / lot number 21c00920 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.A 12-month similar complaint review identified no other similar events have been reported to procept.Aquabeam robotic system user manual, um0104-00 rev.F, was reviewed and states the following: table 4 aquabeam robotic system status indications confirm cartridge is fully seated into pump head and close latch (note: latch provides a tactile click upon closure).The root cause is undeterminable as it is unknown exactly what caused the helical gear to break, however, it is likely that the handpiece pump cartridge was in a suboptimal position while attempting to lock it in place and the force applied caused the helical gear to shatter into pieces.Complaint data is monitored and trended as part of procept's quality management system; shall a trend arise for this failure mode, then further actions will be considered.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: 14570576
• MDR Text Key: 300899015
• Report Number: 3012977056-2022-00076
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190624V
• 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
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male