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

Model Number AB2000

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

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Respiratory Arrest (4461)

Event Date 05/13/2021

Event Type  Injury  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

(b)(6) year old male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that post-aquablation procedure, the patient's prostatic cavity was extremely oozy, causing the urine passing through the balloon catheter to be red.The treating physician injected 100cc and tension placed in the balloon before the patient was taken into the post-anesthesia care unit (pacu).The patient stopped breathing in the pacu but was resuscitated without intubation.Ultimately the medical management in the pacu came down to the patient being hypotensive (low blood pressure) and two (2) units of packed red blood cells (prbcs) were administered.The patient's hemoglobin levels were approximately 10 g/dl with no known pre-operative levels.The transfusion was administered due to the low blood pressure and the patient being possibly under hypovolemic shock.The patient was reported to be in a stable condition and admitted to the intensive care unit (icu) for medical management.The assessment by the treating physician on this event was that the patient was (b)(6) years old and that was part of the risk factor based on his age.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

H.10 additional manufacturer narrative: additional information received confirmed that the patient hospitalized for approximately two (2) weeks due to various reason, such as arrhythmia, ruling out sepsis and the patient having difficulty swallowing and ambulating; both common in elderly patients with prolonged hospital stays.The patient was admitted home after the extended hospital stay and is now home.The aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the log file indicated that the system functioned as designed.A review of the device history record (dhr) for ab2000-b rev b/serial number (b)(6) was performed, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.A review for similar complaints under ab2000-b rev b/serial number 19c00119 confirmed no other similar events reported to procept biorobotics.The aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 4.3.Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o bleeding.The aquabeam robotic system's ifu lists bleeding as a potential risk of the aquablation procedure.The assessment by the treating physician on this event was that the patient was 90 years old and that was part of the risk factor based on his age.No malfunction of the aquabeam robotic system was reported.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 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
• MDR Report Key: 11942996
• MDR Text Key: 260135066
• Report Number: 3012977056-2021-00040
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• 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: 07/01/2021

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 Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 06/26/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 90 YR