AQUABEAM SYSTEM 310301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-23 for AQUABEAM SYSTEM 310301 manufactured by Procept Biorobotics.

Event Text Entries

[146359430] During an aquablation procedure, e22 (r motion error) message occurred. Aquabeam handpiece was replaced and the procedure was completed with no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012977056-2019-00025
MDR Report Key8638811
Report SourceHEALTH PROFESSIONAL
Date Received2019-05-23
Date of Report2019-05-23
Date of Event2019-03-07
Date Mfgr Received2019-04-23
Date Added to Maude2019-05-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINGLI LI
Manufacturer Street900 ISLAND DRIVE, SUITE 210
Manufacturer CityREDWOOD CITY 94065
Manufacturer CountryUS
Manufacturer Postal94065
Manufacturer Phone6502327215
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAQUABEAM SYSTEM
Generic NameFLUID JET REMOVAL SYSTEM
Product CodePZP
Date Received2019-05-23
Returned To Mfg2019-03-07
Model Number310301
Lot Number18C00153
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPROCEPT BIOROBOTICS
Manufacturer Address900 ISLAND DRIVE, SUITE 101 REDWOOD CITY 94065 US 94065


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-23

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