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

Model Number NONE

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/22/2018

Event Type  Injury  

Event Description

Man underwent aquablation for benign prostatic hyperplasia.Several days after the procedure, the patient had hematuria.A blood count showed a low hemoglobin value.The patient underwent transfusion and fulguration of the bladder neck.The patient fully recovered.

Manufacturer Narrative

H.10.Additional manufacturer narrative: a review of the aquabeam system's log file was conducted, which confirmed that there were no anomalies during the procedure.The review indicated that the system functioned as designed.A review of the device history record (dhr) for the aquabeam robotics system, lot number 18c00136, 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), ifu310301, rev.D, lists bleeding as a potential perioperative risk of the aquablation procedure.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.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: 7770183
• MDR Text Key: 116702280
• Report Number: 3012977056-2018-00005
• 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: 01/30/2020

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 Model Number: NONE
• Device Catalogue Number: 210101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention