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

Catalog Number 210101

Device Problem No Apparent Adverse Event (3189)

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

Event Date 09/14/2018

Event Type  malfunction  

Event Description

Male underwent aquablation procedure.During angle planning, physician put his foot on the aquabeam foot pedal and lpp pump error message appeared on the aquabeam cpu.Patient was under spinal anesthesia for a total of ninety (90) minutes before the aquablation procedure was aborted after unsuccessful trouble shooting of the aquabeam cpu.Patient was discharged home subsequently without receiving any treatment.

• Brand Name: AQUABEAM SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer Contact: lingli li ; 900 island drive, suite 210; redwood city, CA 94065 ; 6502327215
• MDR Report Key: 7950628
• MDR Text Key: 123266861
• Report Number: 3012977056-2018-00010
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/26/2018

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: No Information
• Device Catalogue Number: 210101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2016
• 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