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.
[188340343]
A review of the log file was conducted and no anomalies were observed. The review indicated that the system functioned as designed. 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 capsular perforation is listed as a potential perioperative risk of the aquablation procedure. The system was not returned for investigation of this complaint. Capsular 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
[188340344]
A male patient underwent an aquablation procedure. Per standard post-aquablation procedure, during clot evacuation a prostatic capsule perforation was seen by transrectal ultrasound (trus) and later confirmed by cystoscopy (per manufacturer's instructions for use, prostate capsule perforation is a potential perioperative risk of the aquablation procedure). In response to the capsular perforation, the physician decided to leave the foley balloon urinary catheter in place for four (4) days rather than the typical one (1) to two (2) days post-aquablation procedure to allow for healing of the perforation. There were no reported adverse health consequences to the patient following removal of the catheter or as result of the capsular perforation. No malfunction of the aquabeam system was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012977056-2020-00003 |
| MDR Report Key | 9775038 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2018-05-10 |
| Date Mfgr Received | 2018-05-10 |
| 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 |