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 Problem Perforation (2001)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

A review of the log file was conducted and no anomalies were observed.The review indicated that the system functioned as designed.A review of the device history record (dhr) for the aquabeam system, lot number 18c00106, was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system, which could relate to the reported event.The review indicated that the system met all required specifications when released for distribution.The aquabeam system's instructions for use (ifu), ifu320301, rev.D, was reviewed and capsular perforation is listed as a potential perioperative risk of the aquablation procedure.The system was not returned for investigation of this complaint.Capsular perforation is a potential 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.

Event Description

A male patient underwent an aquablation procedure.Per standard post-aquablation procedure, during clot evacuation a prostatic capsule perforation was seen by transrectal ultrasound (trus) and later confirmed by cystoscopy (per manufacturer's instructions for use, prostate capsule perforation is a potential perioperative risk of the aquablation procedure).In response to the capsular perforation, the physician decided to leave the foley balloon urinary catheter in place for four (4) days rather than the typical one (1) to two (2) days post-aquablation procedure to allow for healing of the perforation.There were no reported adverse health consequences to the patient following removal of the catheter or as result of the capsular perforation.No malfunction of the aquabeam system was reported.

• 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: 9775038
• MDR Text Key: 188340343
• Report Number: 3012977056-2020-00003
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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: 03/02/2020

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: 220101
• Device Lot Number: 18C00106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2018
• 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): Hospitalization