MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-12 for AQUABEAM SYSTEM 220101 manufactured by Procept Biorobotics.
[144799712]
Male underwent aquablation procedure. After the procedure, the treating physician decided to take the patient back to the or due to redness of the urinary catheter. Clot evacuation was performed as well as cauterization on the bladder neck. The patient was discharged home the next day. No further sequalae was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012977056-2019-00023 |
| MDR Report Key | 8602472 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-12 |
| Date of Report | 2019-10-29 |
| Date of Event | 2019-04-12 |
| Date Mfgr Received | 2019-10-23 |
| Device Manufacturer Date | 2018-03-08 |
| Date Added to Maude | 2019-05-12 |
| 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 CA 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 | 2019-05-12 |
| Catalog Number | 220101 |
| Lot Number | 18C00146 |
| 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 94065 US 94065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-12 |