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 10/22/2019

Event Type  Injury  

Event Description

Patient underwent aquablation.Per normal post-operative procedure, the patient was catheterized with a foley balloon catheter and rolled into the post-anesthesia care unit (pacu).Approximately an hour later, the patient's catheter began to fluctuate between pink and bright red.The catheter was inflated to an additional 20 cc and traction was increased, but this did not help the color changing from red back to pink.The physician suspected possible bleeding in the prostate (an expected side effect after aquablation) and decided to take the patient back to the operating room (or) and performed cauterization (one of the hemostasis method that is listed in our instructions for use post-aquablation) in the bladder neck region and the prostatic fossa.Following the cauterization, the patient's catheter turned pink and the patient was taken back to the pacu.No further clinical sequela was reported with the patient.

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 19c00548 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 the aquabeam robotic system's, lot number 19c00548, which confirmed that there was one (1) other similar event reported on this lot.The aquabeam robotic system's instructions for use (ifu), ifu320301, rev.F, 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: 9360001
• MDR Text Key: 168201497
• Report Number: 3012977056-2019-00052
• 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: 12/16/2019

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: 19C00548
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention