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

Model Number AB2000

Device Problem Use of Device Problem (1670)

Patient Problem Bowel Perforation (2668)

Event Date 03/26/2021

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

An article published in the world journal of urology reported the results of a multi-center study examining physicians' lessons learned with the aquablation surgical procedure for the treatment of benign prostatic hyperplasia (bph).The article published on 26-mar-2021 reported two (2) patients with rectal perforation, which occurred during aquablation surgical procedures.In the first case, the diagnosis was made two (2) days after the aquablation procedure due to unspecific postoperative symptoms.A complex combined open/endoscopic repair of the defect was carried out thereafter.This event was reported to the agency under mfr.Report # 3012977056-2020-00015.In the second case, intraoperative rectoscopic after uneventful aquablation revealed the rectal perforation.The perforation was clipped immediately with an over the scope-clip by colonoscopy.This mdr is being submitted for the 2nd event.

Manufacturer Narrative

H.10 additional manufacturer narrative: a review of the aquabeam robotic system's log file could not be conducted as the date when the aquablation procedure took place is unknown.A review of the device history record (dhr) for serial number 18c01278 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 device met all design and manufacturing specifications when released for distribution.A review for similar complaints under ab2000/serial number (b)(6) confirmed one (1) other similar event.A review for similar complaints across all systems confirmed seven (7) similar events reported to procept biorobotics.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, rev.B, 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 rectal perforation.A root cause for the reported event could not be determined.The aquabeam robotic system's ifu lists rectal perforation as 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.The information received determined that the rectal perforation was caused by a transrectal ultrasound (trus) probe, which is a non-procept biorobotics device.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: 11721157
• MDR Text Key: 253585789
• Report Number: 3012977056-2021-00025
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• 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
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention