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 SYSTEM 220101 manufactured by Procept Biorobotics Corporation.
[188340177]
A review of the case video was conducted, which included a view of the conformal planning unit (cpu) screen. No system malfunctions were observed. A review of the device history record (dhr) for the aquabeam system, lot number 18c00106, 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. The aquabeam system's instructions for use (ifu), ifu320301, rev. D, was reviewed and bladder perforation is listed as a potential perioperative risk of the aquablation procedure. The system was not returned for investigation of this complaint. Bladder perforation 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
[188340178]
A male patient underwent an aquablation procedure. The foley balloon catheter was removed two (2) days post-aquablation procedure, but the patient began experiencing pelvic pain and was not voiding, although a bladder scan did not show any urinary retention. The physician proceeded to insert new a foley balloon catheter and inflated it to 170cc. After careful review of the post-operative imaging, the physician assessed that this was a capsular perforation very close to the bladder neck. As part of patient management, the foley balloon catheter was left in place for 19 days rather than the typical one (1) to two (2) days post-aquablation procedure to allow for healing of the perforated capsule. The patient fully recovered and was reported to be in good condition. No malfunction of the aquabeam system was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012977056-2020-00004 |
| MDR Report Key | 9775050 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2019-01-09 |
| Date Mfgr Received | 2019-01-09 |
| Device Manufacturer Date | 2018-02-09 |
| 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 SYSTEM |
| Generic Name | FLUID JET REMOVAL SYSTEM |
| Product Code | PZP |
| Date Received | 2020-03-02 |
| Catalog Number | 220101 |
| Lot Number | 18C00106 |
| 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. Hospitalization | 2020-03-02 |