MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-13 for AQUABEAM SYSTEM 220101 manufactured by Procept Biorobotics Corporation.
[188339533]
The physician reported that the rectal perforation occurred as the transrectal ultrasound (trus) probe (non-procept device) was being manually inserted into the patient's rectum and prior to attachment of the aquabeam trus articulating arm and trus stepper. The physician reported that the trus probe was pushed into the patient's rectum against resistance, causing the perforation. The physician indicated that the aquabeam system did not cause or contribute to the event. The aquabeam robotic system's instructions for use (ifu), ifu320301, was reviewed and rectal perforation is listed as a potential perioperative risk of the aquablation procedure. In summary, the treating physician concluded that the serious injury was due to user error with respect to the transrectal ultrasound (trus) probe, and that the aquabeam system did not cause or contribute to the event.
Patient Sequence No: 1, Text Type: N, H10
[188339534]
A male patient underwent an aquablation procedure. Post-aquablation procedure, the patient developed fever and a swollen scrotum in the post-anesthesia care unit (pacu). Upon completion of a ct scan and an abdominal x-ray, it was confirmed that the patient had a rectal perforation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012977056-2020-00002 |
| MDR Report Key | 9707841 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2018-03-07 |
| Date Mfgr Received | 2018-04-03 |
| Device Manufacturer Date | 2018-03-15 |
| Date Added to Maude | 2020-02-13 |
| 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 | 2020-02-13 |
| Catalog Number | 220101 |
| Lot Number | 18C00152 |
| 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. Life Threatening | 2020-02-13 |