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

Model Number AB2000

Device Problem Insufficient Information (3190)

Patient Problem Urinary Retention (2119)

Event Date 03/01/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).On (b)(6) 2022, the patient reported to procept biorobotics corporation being unable to void and still having obstructions, which will require an additional procedure to address.No further information is available on this event.Per the manufacturer's instructions for use, no claim is made that the aquabeam robotic system will cure any medication condition or entirely eliminate the diseased entity.Repeated treatment or alternative therapies may sometimes be required.

Manufacturer Narrative

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

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam robotic system was not returned for investigation of this event and is currently in use at the user facility.A review of the treatment log files was unable to be conducted as it was not possible to determine the date when the aquablation procedure was performed.The investigation consisted of a review of the information reported to procept, plus a review of device history record (dhr) and labeling.A review of the device history record (dhr) ab2000-b rev.C/serial number (b)(6) was conducted, which confirmed that there were no non-conformances, 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.Aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 5.Precautions 5.1 precautions: general · no claim is made that the aquabeam robotic system will cure any medical condition or entirely eliminate the diseased entity.Repeated treatment or alternative therapies may sometimes be required.A root cause for the reported event could not be determined.Per the aquabeam robotic system instructions for use, no claim is made that the aquabeam robotic system will cure any medical condition or entirely eliminate the diseased entity.Repeated treatment or alternative therapies may sometimes be required.Based on the review of the information obtained plus a review of the 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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 15626945
• MDR Text Key: 301944717
• Report Number: 3012977056-2022-00140
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190604X
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 11/15/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male