MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-20 for AQUABEAM SYSTEM 220501 manufactured by Procept Biorobotics Corporation.
| Report Number | 3012977056-2019-00053 |
| MDR Report Key | 9351302 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-11-20 |
| Date of Report | 2019-11-20 |
| Date of Event | 2019-06-24 |
| Date Mfgr Received | 2019-06-24 |
| Device Manufacturer Date | 2018-10-10 |
| Date Added to Maude | 2019-11-20 |
| 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 | 6502695763 |
| Manufacturer G1 | PROCEPT BIOROBOTICS CORPORATION |
| Manufacturer Street | 900 ISLAND DRIVE SUITE 101 |
| Manufacturer City | REDWOOD CITY CA 940651494 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 940651494 |
| 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 | 2019-11-20 |
| Returned To Mfg | 2019-07-10 |
| Catalog Number | 220501 |
| Lot Number | 18C00997 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCEPT BIOROBOTICS CORPORATION |
| Manufacturer Address | 900 ISLAND DRIVE SUITE 101 REDWOOD CITY CA 940651494 US 940651494 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-20 |