MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-04 for AQUABEAM ROBOTIC SYSTEM AB2000 manufactured by Procept Biorobotics.
Report Number | 3012977056-2019-00043 |
MDR Report Key | 9158320 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2019-10-04 |
Date of Report | 2019-11-05 |
Date of Event | 2019-08-12 |
Date Mfgr Received | 2019-11-04 |
Device Manufacturer Date | 2019-05-20 |
Date Added to Maude | 2019-10-04 |
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 101 |
Manufacturer City | REDWOOD CITY CA 940651494 |
Manufacturer Country | US |
Manufacturer Postal | 940651494 |
Manufacturer Phone | 6502327215 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AQUABEAM ROBOTIC SYSTEM |
Generic Name | FLUID JET REMOVAL SYSTEM |
Product Code | PZP |
Date Received | 2019-10-04 |
Model Number | AB2000 |
Catalog Number | AB2000 |
Lot Number | 19C00526 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | PROCEPT BIOROBOTICS |
Manufacturer Address | 900 ISLAND DRIVE, SUITE 101 REDWOOD CITY CA 94065 US 94065 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-10-04 |