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

Catalog Number 220101

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

Patient Problems Perforation (2001); Bowel Perforation (2668)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

The physician reported that the rectal perforation occurred as the transrectal ultrasound (trus) probe (non-procept device) was being manually inserted into the patient's rectum and prior to attachment of the aquabeam trus articulating arm and trus stepper.The physician reported that the trus probe was pushed into the patient's rectum against resistance, causing the perforation.The physician indicated that the aquabeam system did not cause or contribute to the event.The aquabeam robotic system's instructions for use (ifu), ifu320301, was reviewed and rectal perforation is listed as a potential perioperative risk of the aquablation procedure.In summary, the treating physician concluded that the serious injury was due to user error with respect to the transrectal ultrasound (trus) probe, and that the aquabeam system did not cause or contribute to the event.

Event Description

A male patient underwent an aquablation procedure.Post-aquablation procedure, the patient developed fever and a swollen scrotum in the post-anesthesia care unit (pacu).Upon completion of a ct scan and an abdominal x-ray, it was confirmed that the patient had a rectal perforation.

• Brand Name: AQUABEAM SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city, ca
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city, ca
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 170; redwood city, ca ; 2327291
• MDR Report Key: 9707841
• MDR Text Key: 188339533
• Report Number: 3012977056-2020-00002
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 220101
• Device Lot Number: 18C00152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening