MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-02 for AQUABEAM ROBOTIC SYSTEM AB2000 manufactured by Procept Biorobotics Corporation.
[188341255]
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 robotic system, lot number 19c00447, was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system, which could relate to the reported event. The review indicated that the system met all required specifications when released for distribution. A review for similar events was conducted on the aquabeam robotic system, lot number 19c00447, which confirmed there were no other similar events reported on this system. The aquabeam robotic system's instructions for use (ifu), ifu310301, rev. F, was reviewed and urinary retention is listed as a potential perioperative risk of the aquablation procedure. The system was not returned for investigation of this complaint. Based on the review of the log file, dhr, and ifu, the event is considered not to be device related. Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[188341256]
A male patient underwent an aquablation procedure on (b)(6) 2019 and discharged home two (2) days later. Two (2) days post discharge, the patient presented to the emergency room with urinary retention (per manufacturer's instructions for use, urinary retention is listed as a potential perioperative risk of the aquablation procedure) and what appeared to be clots in the bladder. The patient was sent to the operating room for clot evacuation of the bladder. A cystoscopic procedure confirmed no clots were present in the bladder, but rather an intravesical prostatic protrusion, which was likely causing the urinary retention. Procept has conducted multiple attempts to gather additional information from the treating physician regarding course of action taken and condition of the patient without success. No further information has been provided to procept. No malfunction of the aquabeam robotic system was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012977056-2020-00007 |
| MDR Report Key | 9775045 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2019-06-24 |
| Date Mfgr Received | 2019-06-24 |
| Device Manufacturer Date | 2019-04-19 |
| Date Added to Maude | 2020-03-02 |
| 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 | 2020-03-02 |
| Model Number | AB2000 |
| Catalog Number | AB2000 |
| Lot Number | 19C00447 |
| 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 | 2020-03-02 |