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

Catalog Number AB2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/01/2019

Event Type  Injury  

Event Description

Male patient underwent an aquablation procedure.As part of the aquablation procedure, spot cautery around the bladder neck was performed followed by a foley balloon catheter insertion, but the physician encountered difficulty with placement; no urinary catheter guidewire was used despite being recommended by the procept representative present during the procedure.The foley balloon catheter color was light pink when the patient was taken out of the operating room (or) and into the recovery room.During post-operative recovery the foley balloon catheter turned red (per manufacturer's instructions for use, bleeding is a potential risk post-aquablation procedure); ultrasound image of catheter and bladder revealed what appeared to be an obstruction.The patient was taken back to the or and a cystoscopic examination showed that the foley balloon catheter was displaced.Little spot cautery at the bladder neck was performed and a new foley balloon catheter was inserted with the aid of a urinary catheter guidewire; the catheter color was clear.No other clinical sequela was reported with the patient.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

The aquabeam robotic system's log file was reviewed, which confirmed no malfunctions related to the reported event.The review of the log file indicated that the system functioned as designed.A review of the device history record (dhr) for lot number 19c00646 was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications when released for distribution.A review for similar complaints was performed on aquabeam robotic system, lot number 19c00646, which confirmed that there were no other similar complaints found on this lot.The aquabeam robotic system's instructions for use (ifu), ifu320301, rev.D, was reviewed and "bleeding" is listed as a potential perioperative risk of the aquablation procedure.The system was not returned for investigation of this event.A root cause for the reported event could not be determined.Bleeding is an anticipated perioperative 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.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• MDR Report Key: 9433774
• MDR Text Key: 170683791
• Report Number: 3012977056-2019-00063
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: AB2000
• Device Lot Number: 19C00646
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention