MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for AQUABEAM ROBOTIC SYSTEM AB2000 manufactured by Procept Biorobotics Corporation.
[188341689]
A review of the system's log file was conducted, which confirmed that there were no malfunctions observed during the procedure, which could be related to the reported event. The system functioned as designed. A review of the device history record (dhr) serial number (b)(4) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system. The review indicated that the system met all required specifications upon release for distribution. A review for similar events was conducted on the aquabeam robotic system, lot number 19c01641, which confirmed that there were no other similar events reported on this system. The aquabeam robotic system's instructions for use (ifu), ifu0101, rev. C, states the following: 4. 3. Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bleeding. 8. 30. Sterile: after the aquabeam handpiece removal, follow the standard clot evacuation procedure to remove clots and tissue with a cystoscopic sheath by using an ellik bladder evacuator or toomey syringe. Use one of the following methods to achieve hemostasis: non-resective bladder neck cautery followed by foley balloon catheter insertion. The system was not returned for investigation of this event. Bleeding is a potential risk of the aquablation procedure. Based on the review of the log file, dhr, and ifu, the event is considered not to be device related.
Patient Sequence No: 1, Text Type: N, H10
[188341690]
A male patient underwent an aquablation procedure. Post-aquablation procedure, the patient was taken back to the operating room for debridement and cauterization to address bleeding (per manufacturer's instructions for use, bleeding is a potential risk of the aquablation procedure). Additional information was later received that the patient received a blood transfusion (number of units unknown) and was discharged in good condition two (2) days post-aquablation procedure. No malfunction of the aquabeam system was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012977056-2020-00012 |
| MDR Report Key | 9908521 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-12-19 |
| Date Added to Maude | 2020-03-31 |
| 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. DORIA ESQUIVEL |
| Manufacturer Street | 900 ISLAND DRIVE SUITE 170 |
| Manufacturer City | REDWOOD CITY, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 2327291 |
| Manufacturer G1 | PROCEPT BIOROBOTICS CORPORATION |
| Manufacturer Street | 900 ISLAND DRIVE SUITE 101 |
| Manufacturer City | REDWOOD CITY, CA |
| Manufacturer Country | US |
| 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 | 2020-03-31 |
| Model Number | AB2000 |
| Catalog Number | AB2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCEPT BIOROBOTICS CORPORATION |
| Manufacturer Address | 900 ISLAND DRIVE SUITE 101 REDWOOD CITY, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |