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.
[146359410]
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
Report Number | 3012977056-2019-00024 |
MDR Report Key | 8638806 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2019-05-23 |
Date of Report | 2019-05-23 |
Date of Event | 2019-03-07 |
Date Mfgr Received | 2019-04-23 |
Date Added to Maude | 2019-05-23 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. LINGLI LI |
Manufacturer Street | 900 ISLAND DRIVE, SUITE 210 |
Manufacturer City | REDWOOD CITY 94065 |
Manufacturer Country | US |
Manufacturer Postal | 94065 |
Manufacturer Phone | 6502327215 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AQUABEAM SYSTEM |
Generic Name | FLUID JET REMOVAL SYSTEM |
Product Code | PZP |
Date Received | 2019-05-23 |
Returned To Mfg | 2019-03-07 |
Model Number | 310301 |
Lot Number | 18C00153 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | PROCEPT BIOROBOTICS |
Manufacturer Address | 900 ISLAND DRIVE, SUITE 101 REDWOOD CITY 94065 US 94065 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-05-23 |