MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-20 for AQUABEAM SYSTEM 210101 manufactured by Procept Biorobotics Corporation.
[188341518]
A review of the system's log file was conducted, which confirmed that there were no malfunctions observed during the procedure. No system malfunctions were observed. A review of the device history record (dhr) for the aquabeam system, lot number 18c00639, 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 18c00639, 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: 3. Contraindications: do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use. In addition, do not use the system in the following: unable to safely stop anticoagulants or antiplatelet agents perioperatively. 4. 3. Warnings: procedure: as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bleeding. The system was not returned for investigation of this event. Bleeding is a potential risk of the aquablation procedure. Per the ifu, the patient must be able to safely stop anticoagulant agents perioperatively. 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
[188341519]
A male patient underwent an aquablation procedure. The patient had a medical history of being on levonox and pradaxa anticoagulant medications (per the manufacturer's instructions for use, patients must be able to safely stop anticoagulant agents before surgery). Twenty-four hours post discharge, the patient was readmitted due to bleeding (per manufacturer's instructions for use, bleeding is a potential risk of the aquablation procedure). The patient received a blood transfusion (number of units unknown) and was reported to be in good condition with no further clinical sequela. No malfunction of the aquabeam system was reported. Additional information was received that the patient was put back on levonox and pradaxa approximately after 12 hours post-surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012977056-2020-00011 |
| MDR Report Key | 9860862 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2018-07-26 |
| Date Added to Maude | 2020-03-20 |
| 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. 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 SYSTEM |
| Generic Name | FLUID JET REMOVAL SYSTEM |
| Product Code | PZP |
| Date Received | 2020-03-20 |
| Model Number | 210101 |
| Catalog Number | 210101 |
| Lot Number | 18C00639 |
| 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 | 2020-03-20 |