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

Catalog Number AB2000

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

Patient Problems Incontinence (1928); Sexual Dysfunction (4510)

Event Type  Injury  

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.

Event Description

A patient reported to procept biorobotics corporation (procept) having a procedure in (b)(6) 2021 and the following day having emergency surgery and being drained fluid from the abdomen.The patient reported experiencing incontinence and ejaculatory dysfunction.No other details were provided to procept.Per manufacturer instructions for use, incontinence or overactive bladder and ejaculatory dysfunction are potential risks of the aquablation procedure.Procept is in the process of attempting to find out additional information on this event, including whether the patient underwent an aquablation procedure, which was unable to be determined with the initial information provided.

Manufacturer Narrative

Three good faith efforts (gfes) were made to obtain additional information and it was not possible to confirm the user facility where the event occurred or whether this patient had undergone an aquablation procedure.The investigation consisted of a review of the information reported to procept, plus a review the device's labeling.The aquabeam robotic system instructions for use (ifu), ifu0104-00, rev.C, was reviewed and states the following: 4.3.Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: incontinence or overactive bladder; sexual dysfunction, including ejaculatory and erectile dysfunction.A root cause for the reported event could not be determined.The aquabeam robotic system instructions for use list incontinence or overactive bladder and sexual dysfunction, including ejaculatory and erectile dysfunction as potential risks 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 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: 15716837
• MDR Text Key: 302876137
• Report Number: 3012977056-2022-00146
• Device Sequence Number: 1
• Product Code: PZP
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: No
• 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; Other
• Patient Sex: Male