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

Model Number NONE

Device Problem Use of Device Problem (1670)

Patient Problem Bowel Perforation (2668)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

Review of available imaging suggested that rectal perforation was most likely caused by the transrectal ultrasound (trus) probe ((b)(4) model #8848).Perforation was not caused by the waterjet or the transurethral aquabeam handpiece.

Event Description

A man underwent aquablation for symptomatic benign prostatic hyperplasia.Patient had history of rectal polyps and diverticulitis.Two days after an uneventful aquablation procedure he developed abdominal pain with peritoneal signs.Abdominal ct showed free air in the abdomen.He underwent laparotomy during which a 1 cm rectal perforation in the anterior rectum 2 cm beyond the prostate was observed.

Manufacturer Narrative

Subsequent investigation into this event concluded that the rectal perforation was likely caused by the physician exerting excessive upward pressure of the trus probe on the anterior rectum.This was confirmed by ultrasound images that showed the prostate being wrapped around the probe.The posterior-most aspect of the prostate could not be seen, consistent with excessive force being applied.The aquabeam system's instructions for use (ifu), ifu320301, rev.D, lists rectal perforation as a potential perioperative risk of the aquablation procedure.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 SYSTEM FOR PROSTATE TISSUE REMOVAL
• Manufacturer (Section D): PROCEPT BIOROBOTICS; 900 island drive, suite 210; redwood city CA 94065
• MDR Report Key: 7481214
• MDR Text Key: 107163250
• Report Number: 3012977056-2018-00001
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B6142101011
• UDI-Public: B6142101011
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: NONE
• Device Catalogue Number: 220101
• Device Lot Number: 16C0055-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2019
• 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