MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABEAM SYSTEM; FLUID JET REMOVAL SYSTEM

Model Number	210101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the aquabeam system's log file was conducted, which confirmed that there were no malfunctions related to the reported event.The review indicated that the system functioned as designed.A review of the device history record (dhr) was conducted for lot number 18c00487, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the device met specifications when released for distribution.A review of similar complaints was conducted on lot number 18c00487, which confirmed that there were no other similar events reported on this lot.The aquabeam robotic system's user manual (um), um210101, rev.E, lists potential perioperative risks of the aquablation procedure.A root cause for the reported event could not be determined.Based on review of the log file, dhr and um, the event is considered not to be device related.
Event or Problem Description
It was reported that a patient was taken back to the operating room (or) to remove a clot that was obstructing the foley balloon catheter post an aquablation procedure.After placement, the foley balloon catheter ended up in the prostate fossa rather than the bladder neck, which resulted in the clot formation and required repositioning.Clot evacuation was performed with a toomey syringe; no cauterization was used.The foley balloon catheter was repositioned in the bladder neck.No further clinical sequela was reported with the patient.There was no malfunction of the aquabeam system observed during the procedure.
Additional Manufacturer Narrative
H11: corrected data: for corrected data, please refer to section h6 event problem and evaluation codes, patient code(s).

• Brand Name: AQUABEAM SYSTEM
• Common Device Name: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• MDR Report Key: 9329863
• Report Number: 3012977056-2019-00055
• Device Sequence Number: 2243836
• Product Code: PZP
• UDI-Device Identifier: B6142101011
• UDI-Public: B6142101011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: DEN170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 210101
• Device Catalogue Number: 210101
• Device Lot Number: 18C00487
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 08/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention