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 12/05/2019

Event Type  Injury  

Manufacturer Narrative

A review of the aquabeam robotics system's log file 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 the aquabeam robotics system, lot number 19c00550, 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.A review for similar complaints on the aquabeam robotics system, lot number 19c00550, confirmed that there have been no other similar events reported on this system.The aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.C, was reviewed and bleeding is listed as a potential perioperative risk of the aquablation procedure.The system was not returned for investigation of this complaint.Bleeding 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-operative procedure, the patient was catheterized with a foley balloon catheter and taken into the recovery room.Later the same day, the patient's catheter turned red and could not be cleared (per manufacturer's instructions for use, bleeding is a potential risk post-aquablation procedure); therefore, was readmitted as an emergency to the operating room (or).A cystoscopy procedure confirmed remnant of the resected medial lobe; an irregular flag at the base of the bladder neck was found to be bleeding.The area was resected and cauterized followed by insertion of a new foley balloon catheter.The patient was discharged the following day without any further clinical sequela.No malfunction of the aquabeam robotic system was reported.

• 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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 170; redwood city, CA 94065-1494 ; 6502327291
• MDR Report Key: 9594211
• MDR Text Key: 188338822
• Report Number: 3012977056-2020-00001
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/15/2020

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: AB2000
• Device Lot Number: 19C00550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2019
• 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): Required Intervention