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

Catalog Number 220101

Device Problem Nonstandard Device (1420)

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

Event Date 02/20/2019

Event Type  malfunction  

Event Description

Male underwent aquablation procedure.During the procedure, e22 (r motion error) message occurred twice and the treating physician decided to perform transurethral resection of the prostate (turp) instead.No patient injury was reported.

Manufacturer Narrative

H.10.[x] additional manufacturer narrative the aquabeam handpiece was returned for investigation.The aquabeam handpiece was connected to an aquabeam system and a test aquablation treatment run was performed; a persistent e22 error was observed.The test treatment procedure was able to be completed.The handpiece was disconnected, the outer shell was removed, and the handpiece was connected again to the aquabeam system and a test treatment run was performed without the outer shell.A leak was observed at the p1080 probe tube to p1160 pump cartridge distal crimp laser weld.The weld leak resulted in saline leaking on the sensor board, which caused an r position lost error.The error is displayed to the user as an e22 error on the aquabeam cpu.The investigation confirmed the weld leak likely caused the reported e22 error.The reported event was confirmed during the investigation.Root cause investigation into this issue determined that the micro-crack that can develop in a weld joint within the handpiece, and cause the failure mode, is due to variability in a single pass welding process.The contributing factors to the variability were identified through a fish bone analysis and are listed below.1.Weld placement.2.Component gap.3.Weld design.4.Weld inspection.5.Material compatibility.6.Increase in production volume.Multiple long-term corrective and preventive actions were established to further address the underlying factors identified.This event is part of recall 3012977056-030619-001-r.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

For corrected data, please refer to section h.1 type of reportable event, follow-up #1 was incorrectly submitted as "serious injury.".

• Brand Name: AQUABEAM SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• MDR Report Key: 8438614
• MDR Text Key: 139424022
• Report Number: 3012977056-2019-00011
• Device Sequence Number: 1
• Product Code: PZP
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2021

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 Catalogue Number: 220101
• Device Lot Number: 18C00799
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/27/2019; 05/21/2021
• Supplement Dates FDA Received: 02/06/2020; 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3012977056-030619-001-R
• Patient Sequence Number: 1