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

Catalog Number AB2000

Device Problem Use of Device Problem (1670)

Patient Problem Bowel Perforation (2668)

Event Date 08/26/2019

Event Type  Injury  

Event Description

Male underwent aquablation procedure.The patient was in pain within the acute abdomen two days post-op.Ct was performed and free air was found in the abdomen.Laparotomy was performed and pus was found in the small pelvis and a 1-2 mm perforation in the rectum was confirmed.Temporary artificial anus (anus praeter) was constructed.The bladder was okay, and the urine was clear.A follow-up call with the treating physician revealed that the perforation was isolated to anterior rectal wall below the bladder.Confirmed that there was no perforation in bladder or prostate (with contrast), therefore confirmed not to be caused by the aquablation treatment.As a result, the doctor has not yet removed the foley catheter from patient just to be on the conservative side.

Manufacturer Narrative

A review of the aquabeam system's log file was conducted, which confirmed that patient movement was observed during trus insertion at a time of 14:54:11.The handpiece was observed to have been primed between 14:55:56 and 14:56:16 and inserted between 14:56:41 and 15:02:03.No malfunctions were observed during the review of the log file.A review of the device history record (dhr) was conducted for lot number 19c00265, 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 for similar complaints was performed on lot number 19c00265, which confirmed that there were no other similar events reported.The aquabeam robotic system's instructions for use (ifu), ifu310301, was reviewed and "rectal perforation" is listed as potential perioperative risk of the aquablation procedure.The system was not returned for investigation of this complaint.Based on the review of the log file, dhr, and ifu, the event is considered not to be device related.The patient was under spinal anesthesia, which clarifies the movement observed during the log file review and it is likely when the rectal perforation might had occurred.A root cause for the reported event could not be determined.It is possible that the rectal perforation occurred during the patient movement observed on the log file.Rectal perforation is an anticipated perioperative risk of the aquablation procedure.For corrected data, please refer to catalog #.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: AQUABEAM SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS; 900 island drive, suite 101; redwood city 94065
• MDR Report Key: 9121212
• MDR Text Key: 160107035
• Report Number: 3012977056-2019-00040
• Device Sequence Number: 1
• Product Code: PZP
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• 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: 19C00265
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BK MEDICAL TRANSRECTAL ULTRASOUND; BK MEDICAL TRANSRECTAL ULTRASOUND
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention