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

Model Number AB2000

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

Patient Problem Sudden Cardiac Death (2510)

Event Date 05/13/2019

Event Type  Death  

Event Description

(b)(6) year old male with 95 gm prostate underwent aquablation procedure.Patient had a cardiac event the next day in recovery and could not be resuscitated.Patient had been in the hospital for 60 days prior to the surgery due to other comorbidities which included a cardiac event (date not specified) during a routine cystoscopy, he was cleared for undergoing surgery with general anesthesia by the hospital and presented with no intra- or post-operative injuries/complications during and after the aquablation procedure.The treating physician confirmed that a direct connection with the surgical procedure itself, which was complication-free, is very unlikely.Procept has elected to report the death through the mdr system.

Manufacturer Narrative

The aquabeam robotic system's log file were unavailable for review.A review of the device history record (dhr) for lot number 18c00283 was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications when released for distribution.A review for similar complaints was performed on lot number 18c00283, which confirmed that there were no other similar events reported on this lot.The aquabeam robotic system's instructions for use (ifu), ifu310301, provides a list of potential risks associated with the aquablation procedure; however, this event was unlikely related to the aquablation procedure, as stated by the treating physician.The system was not returned for investigation of this event.A root cause for the reported event could not be determined.Based on the review of the dhr, ifu, and information received from the treating physician, the event is considered not to be device related.Corrected data: for corrected data refer to catalog #.The initial report had the catalog # listed incorrectly under model #.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

H.11.Corrected data: for corrected data refer to h.1 type of reportable event.Under follow-up #1 "serious injury" was incorrectly selected as the type of reportable event, the correct selection should have been "death" as indicated in the initial report.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS; 900 island drive, suite 101; redwood city 94065
• MDR Report Key: 8698278
• MDR Text Key: 147992999
• Report Number: 3012977056-2019-00028
• 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,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AB2000
• Device Catalogue Number: AB2000
• Device Lot Number: 18C00283
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR