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

Catalog Number 220101

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/06/2018

Event Type  Injury  

Event Description

Male patient underwent aquablation procedure on (b)(6) 2018.Patient was brought back the or for cauterization to address post-operative bleeding, and transfusion was given due to heavy bleeding.The treating physician reported the patient was doing fine and no further sequelae was noted the day after the procedure.

Manufacturer Narrative

H.10.Additional manufacturer narrative: a review of the device history record (dhr) for lot number 18c00152 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, lists bleeding as a potential perioperative risk of the aquablation procedure.A review of similar complaints was conducted, which confirmed that other events have been reported on this system.The system was not returned for investigation.Based on the review of the dhr, and ifu, the event is considered not to be device related.Bleeding is 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 REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS; 900 island drive, suite 101; redwood city 94065
• MDR Report Key: 8125670
• MDR Text Key: 129078688
• Report Number: 3012977056-2018-00014
• 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: 02/03/2020

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: No Information
• Device Catalogue Number: 220101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention